First-in-Human (FIH) Trial of GEN3009 in Subjects With Re... | NCT04358458

NCT04358458

ID	Type	Description	Link
2019-002752-16	EudraCT Number
NL72025.056.20	Registry Identifier	The Netherlands CCMO

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Monotherapy Arm	Experimental		Biological: GEN3009
Combination Arm	Experimental		Biological: GEN3009 Biological: Epcoritamab

Name	Type	Description	Arm Group Labels	Other Names
GEN3009	Biological	GEN3009 will be administered by intravenous (IV) infusion in cycles of 28 days	Combination Arm Monotherapy Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs)	DLTs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, except for TLS (Cairo-Bishop grading) and CRS/ICANS (Lee et al., 2019). These criteria include: all Grade 5 toxicities; hematologic events including thrombocytopenia Grade 4, neutropenia Grade 4, Febrile neutropenia Grade 3 or 4, Grade 3 or 4 hemorrhage associated with thrombocytopenia of ≥Grade 3, anemia of Grade 4 and tumor lysis syndrome (TLS) Grade 4; and non-hematologic AEs of Grade 3 or higher excluding certain fevers, hypotension, laboratory values, Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT), nausea, vomiting, diarrhea, fatigue/asthenia, or alopecia (no grading), which meet certain additional criteria.	During the first treatment cycle (Cycle length=28 days)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs	An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as an AE that meets one of the following criteria: is fatal or life-threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; is medically significant (an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above [medical and scientific judgment must be exercised in deciding whether an AE is "medically significant"]); required inpatient hospitalization or prolongation of existing hospitalization. TEAEs are defined as AEs which begin, or worsen, during the on-treatment period ending 4 weeks after the last dose of study medication.	From first dose until 30 days after the last dose (up to 15.5 months)
Number of Participants With AEs of Special Interest (AESI)	AESIs are defined as events (serious or non-serious) that are of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor may be appropriate.

Secondary Outcomes

Measure	Description	Time Frame
Apparent Total Plasma Clearance (CL) of GEN3009		Pre-dose and 5 minutes post-dose on days 1, 2, 4 (S2 only), 8, 15, 22 and 2 hours (h) and 4h post-dose on days 1 and 2, 24h post-dose on day 2 and 72h post-dose on day 4 of Cycles 1 and 2 (Each cycle length=28 days)
Volume of Distribution of GEN3009

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Be at least 18 years of age.
Must sign an informed consent form prior to any screening procedures.
Dose Escalation: Has histologically or cytologically confirmed relapsed and/or refractory B-cell NHL with no available standard therapy or is not a candidate for available standard therapy, and for whom, in the opinion of the investigator, the experimental therapy may be beneficial. All subjects must have received at least two prior lines of systemic therapy.

Dose Expansion: Has histologically or cytologically confirmed relapsed or refractory B-cell NHL. All subjects must have received at least 2 prior lines of systemic therapy, and,
1. For FL and DLBCL, at least 1 of the 2 prior lines of treatment must have been a CD20 containing systemic regimen;
2. For CLL, subjects must have received at least one prior line of BTK inhibitor or BCL 2 inhibitor.
Has one of the eligible subtypes of B-cell NHL :

Dose Escalation: (DLBCL, HGBCL, PMBCL, FL, MCL, MZL, SLL, or CLL). Dose Expansion: (DLBCL, FL, CLL)
Has measurable disease for B-cell NHL or has active disease for Chronic Lymphocytic Leukemia (CLL).
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Has adequate hepatic, renal, and bone marrow functions.
Before the first dose of GEN3009, during the trial, and for 12 months after the last dose of GEN3009 and/or the combination, a woman must be either not of childbearing potential or of childbearing potential and practicing a highly effective method of birth control, and must have a negative serum beta-human chorionic gonadotropin (beta-hCG) and urine pregnancy test at screening.
A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control.
Subjects must have a life expectancy of at least 3 months.

Key Exclusion Criteria:

Prior treatment with a CD37-targeting agent.
Prior allogeneic Hematopoietic Stem Cell Transplantation (HSCT).
Prior treatment with a CD3xCD20 bispecific antibody (Combination Expansion cohort only).
Autologous HSCT within 3 months before the first dose of GEN3009.
Lymphomas leukemic phase: high absolute lymphocyte count or the presence of abnormal cells in the peripheral blood indicating circulating lymphoma cells.
Treatment with an anti-cancer biologic including anti-CD20 therapy, radio-conjugated or toxin-conjugated antibody or chimeric antigen receptor (CAR) T-cell therapy within 4 weeks or 5 half-lives, whichever is shorter, before the first dose of GEN3009. Treatment with small molecules such as BTK inhibitors, BCL2 inhibitors, or PI3K inhibitors within 5 half-lives prior to the first dose of GEN3009.
Chemotherapy or radiation therapy within 2 weeks of the first dose of GEN3009.
Treatment with an investigational drug or an invasive investigational medical device within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of GEN3009, and at any time during the study treatment period.
Autoimmune disease or other diseases that require permanent or high-dose immunosuppressive therapy.
Received a cumulative dose of corticosteroids more than the equivalent of 250 mg of prednisone within the 2-week period before the first dose of GEN3009.
Has uncontrolled intercurrent illness.
Seizure disorder requiring therapy (such as steroids or anti-epileptics) (Combination Expansion cohort only).
Toxicities from previous anti-cancer therapies have not resolved to baseline levels or to Grade 1 or less except for alopecia and peripheral neuropathy.
Primary central nervous system (CNS) lymphoma or known CNS involvement at screening.
Known past or current malignancy other than inclusion diagnosis.
Had allergic reactions to anti-CD20 or anti-CD37 monoclonal antibody treatment or intolerant to GEN3009 or to the combination therapy excipients.
Has had major surgery within 4 weeks before screening or will not have fully recovered from surgery, or has major surgery planned during the time the subject is expected to participate in the trial (or within 4 weeks after the last dose of GEN3009 and/or the combination therapy).
Known history/positive serology for hepatitis B.
Known medical history or ongoing hepatitis C infection that has not been cured.
Known history of seropositivity for HIV infection.
Is a woman who is pregnant or breast-feeding, or who is planning to become pregnant while enrolled in this trial or within 12 months after the last dose of GEN3009 and/or the combination therapy.
Is a man who plans to father a child while enrolled in this trial or within 12 months after the last dose of GEN3009 and/or the combination therapy.
Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. Additionally, vulnerable subjects or subjects under guardianship, curatorship, judicial protection or deprived of liberty), are excluded from participation in this trial.
Exposed to live/live attenuated vaccine within 4 weeks prior to initiation of GEN3009 treatment.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Colorado Blood Cancer Institute		Denver	Colorado	80218	United States
University Hospitals Cleveland Medical Center

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Part 1: GEN3009 Dose Level A in Schedule 1 (S1)	Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 9, 2021	Apr 8, 2024

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

The Full analysis set (FAS) comprises all participants to whom study drug had been assigned and who had received at least 1 dose of GEN3009.

Arm/Group Information

ID	Title	Description
BG000	Part 1: GEN3009 Dose Level A in S1	Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
BG001	Part 1: GEN3009 Dose Level B in S1	Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
BG002	Part 1: GEN3009 Dose Level C in S1	Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
BG003	Part 1: GEN3009 Dose Level D in S1	Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
BG004	Part 1: GEN3009 Dose Level D in S2	Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
BG005	Part 1: GEN3009 Dose Level E in S1	Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
BG006	Part 1: GEN3009 Dose Level F in S1	Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
BG007	Part 1: GEN3009 Dose Level G in S1	Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
BG008	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00065± 3.46 BG00154.5± 8.81 BG00274.6± 8.68 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0002 BG0011 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Ethnicity

Title	Measurements
Missing	BG0000 BG0012 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Race

Title	Measurements
Black or African American	BG0001 BG0011 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Belgium

Title	Measurements
	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Dose Limiting Toxicities (DLTs)

DLTs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, except for TLS (Cairo-Bishop grading) and CRS/ICANS (Lee et al., 2019). These criteria include: all Grade 5 toxicities; hematologic events including thrombocytopenia Grade 4, neutropenia Grade 4, Febrile neutropenia Grade 3 or 4, Grade 3 or 4 hemorrhage associated with thrombocytopenia of ≥Grade 3, anemia of Grade 4 and tumor lysis syndrome (TLS) Grade 4; and non-hematologic AEs of Grade 3 or higher excluding certain fevers, hypotension, laboratory values, Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT), nausea, vomiting, diarrhea, fatigue/asthenia, or alopecia (no grading), which meet certain additional criteria.

The Safety analysis set included all participants who had received at least 1 dose of GEN3009.

Posted

Count of Participants

Participants

During the first treatment cycle (Cycle length=28 days)

ID	Title	Description
OG000	Part 1: GEN3009 Dose Level A in S1	Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG001	Part 1: GEN3009 Dose Level B in S1	Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG002	Part 1: GEN3009 Dose Level C in S1	Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG003	Part 1: GEN3009 Dose Level D in S1	Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
OG004	Part 1: GEN3009 Dose Level D in S2	Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
OG005	Part 1: GEN3009 Dose Level E in S1	Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
OG006	Part 1: GEN3009 Dose Level F in S1	Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
OG007	Part 1: GEN3009 Dose Level G in S1	Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.

Units	Counts
Participants	OG0003 OG0014 OG0027 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Primary

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as an AE that meets one of the following criteria: is fatal or life-threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; is medically significant (an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above [medical and scientific judgment must be exercised in deciding whether an AE is "medically significant"]); required inpatient hospitalization or prolongation of existing hospitalization. TEAEs are defined as AEs which begin, or worsen, during the on-treatment period ending 4 weeks after the last dose of study medication.

The Safety analysis set included all participants who had received at least 1 dose of GEN3009.

Posted

Count of Participants

Participants

From first dose until 30 days after the last dose (up to 15.5 months)

ID	Title	Description
OG000	Part 1: GEN3009 Dose Level A in S1	Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG001	Part 1: GEN3009 Dose Level B in S1

Primary

Number of Participants With AEs of Special Interest (AESI)

AESIs are defined as events (serious or non-serious) that are of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor may be appropriate.

The Safety analysis set included all participants who had received at least 1 dose of GEN3009.

Posted

Count of Participants

Participants

From first dose until 30 days after the last dose (up to 15.5 months)

ID	Title	Description
OG000	Part 1: GEN3009 Dose Level A in S1	Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG001	Part 1: GEN3009 Dose Level B in S1	Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG002	Part 1: GEN3009 Dose Level C in S1

Primary

Number of Participants With Clinically Significant Laboratory Abnormalities Reported as TEAEs

Laboratory parameters included hematology, serum chemistries and urinalysis. Clinically significant laboratory abnormalities were based upon the Investigator's discretion. Laboratory parameters captured as AEs are reported in this outcome measure.

The Safety analysis set included all participants who had received at least 1 dose of GEN3009.

Posted

Count of Participants

Participants

From first dose until 30 days after the last dose (up to 15.5 months)

ID	Title	Description
OG000	Part 1: GEN3009 Dose Level A in S1	Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG001	Part 1: GEN3009 Dose Level B in S1	Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG002	Part 1: GEN3009 Dose Level C in S1

Primary

Number of Participants With Clinically Notable Vital Signs

Criteria for clinically notable (elevated and below normal values respectively) vital signs are as follows: Systolic Blood Pressure (SBP): ≥180 millimeters of mercury (mmHg) and an increase ≥20 mmHg from baseline, ≤90 mmHg and a decrease ≥20 mmHg from baseline; Diastolic Blood Pressure (DBP): ≥105 mmHg and an increase ≥15 mmHg from baseline, ≤50 mmHg and a decrease ≥15 mmHg from baseline; Heart rate: ≥120 beats per minute (bpm) with an increase of ≥15 bpm from baseline, ≤50 bpm and a decrease ≥15 bpm from baseline; Temperature: > 38 degree Celsius (°C) and < 35°C. Number of participants with clinically notable elevated and below normal vital signs values up to end of treatment are reported.

The Safety analysis set included all participants who had received at least 1 dose of GEN3009. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.

Posted

Count of Participants

Participants

From first dose up to end of treatment (up to 14.5 months)

ID	Title	Description
OG000	Part 1: GEN3009 Dose Level A in S1	Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG001	Part 1: GEN3009 Dose Level B in S1

Primary

Number of Participants With Dose Delays and Dose Interruptions

Number of participants with dose delays and dose Interruptions due to AE, Coronavirus disease 2019 (COVID-19), drug administration issues and other unspecified reasons are reported.

The Safety analysis set included all participants who had received at least 1 dose of GEN3009.

Posted

Count of Participants

Participants

From first dose until 30 days after the last dose (up to 15.5 months)

ID	Title	Description
OG000	Part 1: GEN3009 Dose Level A in S1	Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG001	Part 1: GEN3009 Dose Level B in S1	Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG002	Part 1: GEN3009 Dose Level C in S1	Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.

Primary

Actual Dose Intensity

Actual dose intensity (milligrams per cycle [mg/cycle]) is calculated as cumulative dose/number of cycles initiated.

The Safety analysis set included all participants who had received at least 1 dose of GEN3009. 'Number analyzed' indicates the number of participants with data available for analysis at specified cycle duration.

Posted

Mean

Standard Deviation

mg/cycle

From first dose until 30 days after the last dose (up to 15.5 months)

ID	Title	Description
OG000	Part 1: GEN3009 Dose Level A in S1	Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG001	Part 1: GEN3009 Dose Level B in S1	Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG002	Part 1: GEN3009 Dose Level C in S1	Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.

Secondary

Apparent Total Plasma Clearance (CL) of GEN3009

The pharmacokinetic analysis set (PAS) includes all participants who have been exposed to GEN3009 and have had at least one pharmacokinetic sample collected that has provided a valid bioanalytical result.

Posted

Mean

Standard Deviation

Liters per day

Pre-dose and 5 minutes post-dose on days 1, 2, 4 (S2 only), 8, 15, 22 and 2 hours (h) and 4h post-dose on days 1 and 2, 24h post-dose on day 2 and 72h post-dose on day 4 of Cycles 1 and 2 (Each cycle length=28 days)

ID	Title	Description
OG000	Part 1: GEN3009 Dose Level A in S1	Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG001	Part 1: GEN3009 Dose Level B in S1	Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG002	Part 1: GEN3009 Dose Level C in S1	Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.

Secondary

Volume of Distribution of GEN3009

The PAS includes all participants who have been exposed to GEN3009 and have had at least one pharmacokinetic sample collected that has provided a valid bioanalytical result.

Posted

Mean

Standard Deviation

Pre-dose and 5 minutes post-dose on days 1, 2, 4 (S2 only), 8, 15, 22 and 2h and 4h post-dose on days 1 and 2, 24h post-dose on day 2 and 72h post-dose on day 4 of Cycles 1 and 2 (Each cycle length=28 days)

ID	Title	Description
OG000	Part 1: GEN3009 Dose Level A in S1	Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG001	Part 1: GEN3009 Dose Level B in S1	Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG002	Part 1: GEN3009 Dose Level C in S1	Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.

Secondary

Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Day 7 of GEN3009

The PAS includes all participants who have been exposed to GEN3009 and have had at least one pharmacokinetic sample collected that has provided a valid bioanalytical result. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at a specified cycle.

Posted

Mean

Standard Deviation

micrograms*day per milliliter(ug*day/mL)

Pre-dose and 5 minutes post-dose on days 1, 2 and 4 (S2 only); 2h and 4h post-dose on days 1 and 2, 24h post-dose on day 2 and 72h post-dose on day 4 of Cycles 1 and 2 (Each cycle length=28 days)

ID	Title	Description
OG000	Part 1: GEN3009 Dose Level A in S1	Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG001	Part 1: GEN3009 Dose Level B in S1	Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.

Secondary

AUC From Time 0 to Infinity (AUCinf) of GEN3009

Posted

Mean

Standard Deviation

ug*day/mL

ID	Title	Description
OG000	Part 1: GEN3009 Dose Level A in S1	Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG001	Part 1: GEN3009 Dose Level B in S1	Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG002

Secondary

AUC From Time 0 to Time of Last Dose (AUClast) of GEN3009

The PAS includes all participants who have been exposed to GEN3009 and have had at least one pharmacokinetic sample collected that has provided a valid bioanalytical result. 'Number analyzed' indicates the number of participants with data available for analysis at specified cycle duration.

Posted

Mean

Standard Deviation

ug*day/mL

ID	Title	Description
OG000	Part 1: GEN3009 Dose Level A in S1	Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG001	Part 1: GEN3009 Dose Level B in S1	Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG002	Part 1: GEN3009 Dose Level C in S1

Secondary

Maximum Observed Plasma Concentration (Cmax) of GEN3009

Posted

Mean

Standard Deviation

microgram per milliliter (ug/mL)

ID	Title	Description
OG000	Part 1: GEN3009 Dose Level A in S1	Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG001	Part 1: GEN3009 Dose Level B in S1	Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG002	Part 1: GEN3009 Dose Level C in S1

Secondary

Time to Reach Cmax (Tmax) of GEN3009

Posted

Mean

Standard Deviation

days

ID	Title	Description
OG000	Part 1: GEN3009 Dose Level A in S1	Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG001	Part 1: GEN3009 Dose Level B in S1	Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG002	Part 1: GEN3009 Dose Level C in S1

Secondary

Trough Concentrations (Ctrough) of GEN3009

The PAS includes all participants who have been exposed to GEN3009 and have had at least one pharmacokinetic sample collected that has provided a valid bioanalytical result.

Posted

Mean

Standard Deviation

ug/mL

ID	Title	Description
OG000	Part 1: GEN3009 Dose Level A in S1	Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG001	Part 1: GEN3009 Dose Level B in S1	Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG002	Part 1: GEN3009 Dose Level C in S1	Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.

Secondary

Terminal Elimination Half-Life (t 1/2) of GEN3009

The PAS includes all participants who have been exposed to GEN3009 and have had at least one pharmacokinetic sample collected that has provided a valid bioanalytical result.

Posted

Mean

Standard Deviation

days

ID	Title	Description
OG000	Part 1: GEN3009 Dose Level A in S1	Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG001	Part 1: GEN3009 Dose Level B in S1	Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG002	Part 1: GEN3009 Dose Level C in S1	Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.

Secondary

Number of Participants With Positive Anti-drug Antibodies (ADAs)

Venous blood samples will be collected for measurement of serum concentrations of ADAs. Number of participants with positive ADAs are reported in this outcome measure. The detection of ADAs was performed using validated, specific and sensitive Electrochemiluminescence Immunoassay (ECLIA) method.

The immunogenicity analysis set included all participants who had received at least 1 dose of study drug and had a baseline and at least 1 evaluable on-treatment ADA sample.

Posted

Count of Participants

Participants

From first dose until 30 days after the last dose (up to 15.5 months)

ID	Title	Description
OG000	Part 1: GEN3009 Dose Level A in S1	Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG001	Part 1: GEN3009 Dose Level B in S1	Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG002

Secondary

Duration of Response (DoR)

DoR is defined as the time from the first documentation of objective tumor response [Complete response (CR) or Partial response (PR)] to the date of first disease progression (PD) or death as assessed by the investigator based on Lugano criteria for B-cell non-Hodgkin lymphoma (B-cell NHL) and International Workshop on Chronic Lymphocytic Leukemia (iwCLL) for chronic lymphocytic leukemia (CLL). Detailed definition of CR, PR and PD as per Lugano and iwCLL criteria in the protocol appendices.

The FAS comprises all participants to whom study drug had been assigned and who had received at least 1 dose of GEN3009. 'Overall number of participants Analyzed' signified the participants who achieved CR or PR.

Posted

Median

95% Confidence Interval

months

From date of first documented CR or PR up to disease progression or death (up to approximately 3 years 4 months)

ID	Title	Description
OG000	Part 1: GEN3009 Dose Level A in S1	Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG001	Part 1: GEN3009 Dose Level B in S1	Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.

Secondary

Time to Response (TTR)

TTR: time from first dose of administration until date of first response as assessed by investigator based on Lugano criteria for B-cell NHL and iwCLL for CLL. It is derived for all participants who achieved PR or CR. Detailed definitions of CR, PR and PD as per Lugano and iwCLL criteria in the protocol appendices.

The FAS comprises all participants to whom study drug had been assigned and who had received at least 1 dose of GEN3009. 'Overall number of participants analyzed' indicates the number of participants who achieved CR or PR.

Posted

Mean

Standard Deviation

months

From date of first documented CR or PR up to disease progression or death (up to approximately 3 years 4 months)

ID	Title	Description
OG000	Part 1: GEN3009 Dose Level A in S1	Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG001	Part 1: GEN3009 Dose Level B in S1	Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.

Secondary

Progression-free Survival (PFS)

PFS is defined as the time in days from Day 1 of Cycle 1 to the day of first documented PD, or the day of death due to any cause, whichever comes first as assessed by investigator based on Lugano Criteria for B-cell NHL and iwCLL for CLL. PFS was estimated using the Kaplan-Meier method. Detailed definitions of PD as per Lugano and iwCLL criteria in the protocol appendices.

The FAS comprises all participants to whom study drug had been assigned and who had received at least 1 dose of GEN3009.

Posted

Median

95% Confidence Interval

months

From day of first dose until disease progression or death due to any cause (up to approximately 3 years 4 months)

ID	Title	Description
OG000	Part 1: GEN3009 Dose Level A in S1	Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG001	Part 1: GEN3009 Dose Level B in S1	Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.

Secondary

Overall Survival (OS)

The OS is defined as the time from the start of study treatment until death due to any cause. The OS was estimated using Kaplan-Meier method.

The FAS comprises all participants to whom study drug had been assigned and who had received at least 1 dose of GEN3009.

Posted

Median

95% Confidence Interval

months

From day of first dose until disease progression or death due to any cause (up to approximately 3 years 4 months)

ID	Title	Description
OG000	Part 1: GEN3009 Dose Level A in S1	Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG001	Part 1: GEN3009 Dose Level B in S1	Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG002	Part 1: GEN3009 Dose Level C in S1	Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.

Secondary

Objective Response Rate (ORR)

ORR: the percentage of participants who achieved a best overall response (BOR) of CR or PR as assessed by investigator based on Lugano Criteria for B-cell NHL and iwCLL for CLL. Detailed definitions of CR and PR as per Lugano and iwCLL criteria in the protocol appendices.

The Response Evaluable Set includes all participants in FAS who have baseline evaluable disease and had at least 1 post-baseline disease evaluation or died within 60 days of first trial treatment.

Posted

Number

95% Confidence Interval

percentage of participants

From day of first dose until disease progression or death due to any cause (up to approximately 3 years 4 months)

ID	Title	Description
OG000	Part 1: GEN3009 Dose Level A in S1	Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG001	Part 1: GEN3009 Dose Level B in S1	Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.

Secondary

CR Rate

CR rate was estimated using Clopper-Pearson method. Detailed definitions of CR as per Lugano and iwCLL criteria in the protocol appendices.

The Response Evaluable set includes all participants in FAS who have baseline evaluable disease and had at least 1 post-baseline disease evaluation or died within 60 days of first trial treatment.

Posted

Number

95% Confidence Interval

percentage of participants

From day of first dose until disease progression or death due to any cause (up to approximately 3 years 4 months)

ID	Title	Description
OG000	Part 1: GEN3009 Dose Level A in S1	Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG001	Part 1: GEN3009 Dose Level B in S1	Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
OG002	Part 1: GEN3009 Dose Level C in S1

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part 1: GEN3009 Dose Level A in S1	Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.	1	3	0	3	3	3
EG001	Part 1: GEN3009 Dose Level B in S1	Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.	1	4	0	4	4	4
EG002	Part 1: GEN3009 Dose Level C in S1	Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.	3	7	4	7	7	7
EG003	Part 1: GEN3009 Dose Level D in S1	Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.	8	10	7	10	9	10
EG004	Part 1: GEN3009 Dose Level D in S2	Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.	1	3	2	3	3	3
EG005	Part 1: GEN3009 Dose Level E in S1	Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 8 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.	6	10	4	10	10	10
EG006	Part 1: GEN3009 Dose Level F in S1	Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.	2	3	2	3	3	3
EG007	Part 1: GEN3009 Dose Level G in S1	Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.	3	6	4	6	6	6

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG0031 affected10 at risk EG0040 affected3 at risk EG0050 affected10 at risk EG0060 affected3 at risk EG0070 affected6 at risk
Paronychia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Cellulitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Syncope	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Device related infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Aphasia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
COVID-19 pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
COVID-19	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Dizziness	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG0031 affected10 at risk EG0040 affected3 at risk EG0050 affected10 at risk EG0060 affected3 at risk EG0070 affected6 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Bronchitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0022 affected7 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Ear infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Urinary tract pain	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Cellulitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Scleral haemorrhage	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Rhinovirus infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Restless legs syndrome	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Peripheral motor neuropathy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Cytomegalovirus infection reactivation	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Weight decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Refractive amblyopia	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0020 affected7 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Dry eye	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0012 affected4 at risk EG0020 affected7 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Anosmia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected4 at risk EG0020 affected7 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0022 affected7 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
CD4 lymphocytes decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Malaise	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Injection site phlebitis	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Mucosal inflammation	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0020 affected7 at risk EG003
Fatigue	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected4 at risk EG0022 affected7 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Blood creatine increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Scrotal pain	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Skin atrophy	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Lymph node pain	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Tremor	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected4 at risk EG0020 affected7 at risk EG003
Somnolence	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Candida infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Blood creatinine increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0022 affected7 at risk EG003
Oedema	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0020 affected7 at risk EG003
Asthenia	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0020 affected7 at risk EG003
Lymphocytosis	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected3 at risk EG0014 affected4 at risk EG0027 affected7 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Meralgia paraesthetica	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Hypotension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Oedema peripheral	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Vascular access complication	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Hypogammaglobulinaemia	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Flushing	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Palpitations	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected4 at risk EG0023 affected7 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Pyrexia	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0020 affected7 at risk EG003
Delirium	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Aphasia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Injection site reaction	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Chills	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Feeling jittery	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Influenza like illness	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0021 affected7 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Photophobia	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Diplopia	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Vein disorder	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected3 at risk EG0012 affected4 at risk EG0023 affected7 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0020 affected7 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0020 affected7 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0020 affected7 at risk EG003
Scratch	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Gingival pain	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0020 affected7 at risk EG003
COVID-19	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0022 affected7 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected4 at risk EG0027 affected7 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Periorbital oedema	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Dizziness	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Steroid diabetes	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Phlebitis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Dermoid cyst	Congenital, familial and genetic disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected3 at risk EG0012 affected4 at risk EG0022 affected7 at risk EG003
Dizziness postural	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected3 at risk EG0011 affected4 at risk EG0021 affected7 at risk EG003
Hypertension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
International normalised ratio increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0022 affected7 at risk EG003
Coordination abnormal	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Infusion site paraesthesia	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0013 affected4 at risk EG0023 affected7 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected7 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected7 at risk EG003

The trial was terminated due to strategic evaluation of GEN3009 within context of Genmab's portfolio, decision not based on any safety or regulatory concerns.

Certain Agreements

First MCP Posted Date

ID	Term
D016403	Lymphoma, Large B-Cell, Diffuse
D008224	Lymphoma, Follicular
D018442	Lymphoma, B-Cell, Marginal Zone
D015451	Leukemia, Lymphocytic, Chronic, B-Cell
D020522	Lymphoma, Mantle-Cell

Ancestor Terms

ID	Term
D016393	Lymphoma, B-Cell
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D007938	Leukemia
D006402	Hematologic Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.

Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.

EG0041 affected3 at risk

EG0050 affected10 at risk

EG0060 affected3 at risk

EG0070 affected6 at risk

EG0040 affected3 at risk

EG0051 affected10 at risk

EG0060 affected3 at risk

EG0070 affected6 at risk

EG0041 affected3 at risk

EG0050 affected10 at risk

EG0060 affected3 at risk

EG0071 affected6 at risk

EG0040 affected3 at risk

EG0051 affected10 at risk

EG0060 affected3 at risk

EG0070 affected6 at risk

EG0040 affected3 at risk

EG0050 affected10 at risk

EG0060 affected3 at risk

EG0070 affected6 at risk

EG0040 affected3 at risk

EG0051 affected10 at risk

EG0060 affected3 at risk

EG0070 affected6 at risk

EG0041 affected3 at risk

EG0050 affected10 at risk

EG0060 affected3 at risk

EG0070 affected6 at risk

EG0041 affected3 at risk

EG0050 affected10 at risk

EG0061 affected3 at risk

EG0070 affected6 at risk

EG0040 affected3 at risk

EG0050 affected10 at risk

EG0060 affected3 at risk

EG0070 affected6 at risk

EG0040 affected3 at risk

EG0050 affected10 at risk

EG0061 affected3 at risk

EG0070 affected6 at risk

EG0040 affected3 at risk

EG0050 affected10 at risk

EG0061 affected3 at risk

EG0071 affected6 at risk

EG0040 affected3 at risk

EG0051 affected10 at risk

EG0060 affected3 at risk

EG0070 affected6 at risk

EG0040 affected3 at risk

EG0050 affected10 at risk

EG0060 affected3 at risk

EG0071 affected6 at risk

EG0040 affected3 at risk

EG0050 affected10 at risk

EG0060 affected3 at risk

EG0070 affected6 at risk

EG0040 affected3 at risk

EG0050 affected10 at risk

EG0060 affected3 at risk

EG0071 affected6 at risk

EG0040 affected3 at risk

EG0050 affected10 at risk

EG0060 affected3 at risk

EG0070 affected6 at risk

EG0040 affected3 at risk

EG0050 affected10 at risk

EG0060 affected3 at risk

EG0070 affected6 at risk

EG0040 affected3 at risk

EG0051 affected10 at risk

EG0060 affected3 at risk

EG0071 affected6 at risk

EG0040 affected3 at risk

EG0051 affected10 at risk

EG0061 affected3 at risk

EG0071 affected6 at risk

EG0040 affected3 at risk

EG0050 affected10 at risk

EG0060 affected3 at risk

EG0070 affected6 at risk

EG0040 affected3 at risk

EG0051 affected10 at risk

EG0060 affected3 at risk

EG0070 affected6 at risk

EG0040 affected3 at risk

EG0050 affected10 at risk

EG0060 affected3 at risk

EG0070 affected6 at risk

EG0040 affected3 at risk

EG0051 affected10 at risk

EG0060 affected3 at risk

EG0070 affected6 at risk

EG0042 affected3 at risk

EG0051 affected10 at risk

EG0061 affected3 at risk

EG0070 affected6 at risk

EG0040 affected3 at risk

EG0050 affected10 at risk

EG0060 affected3 at risk

EG0070 affected6 at risk

EG0040 affected3 at risk

EG0050 affected10 at risk

EG0060 affected3 at risk

EG0071 affected6 at risk

EG0040 affected3 at risk

EG0050 affected10 at risk

EG0060 affected3 at risk

EG0071 affected6 at risk

EG0040 affected3 at risk

EG0050 affected10 at risk

EG0060 affected3 at risk

EG0070 affected6 at risk

EG0040 affected3 at risk

EG0051 affected10 at risk

EG0060 affected3 at risk

EG0070 affected6 at risk

EG0040 affected3 at risk

EG0050 affected10 at risk

EG0060 affected3 at risk

EG0070 affected6 at risk

EG0040 affected3 at risk

EG0050 affected10 at risk

EG0060 affected3 at risk

EG0071 affected6 at risk

EG0040 affected3 at risk

EG0050 affected10 at risk

EG0060 affected3 at risk

EG0070 affected6 at risk

EG0040 affected3 at risk

EG0051 affected10 at risk

EG0062 affected3 at risk

EG0074 affected6 at risk

EG0040 affected3 at risk

EG0050 affected10 at risk

EG0060 affected3 at risk

EG0072 affected6 at risk

EG0040 affected3 at risk

EG0050 affected10 at risk

EG0060 affected3 at risk

EG0070 affected6 at risk

EG0040 affected3 at risk

EG0050 affected10 at risk

EG0060 affected3 at risk

EG0071 affected6 at risk

EG0041 affected3 at risk

EG0050 affected10 at risk