First-in-Human Study of IMGC936 in Participants With Adva... | NCT04622774

NCT04622774

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Sponsor/Collaborators Module

Name	Class
MacroGenics	INDUSTRY

Oversight Module

Description Module

Detailed Description

This is an open-label, dose-escalation, and expansion study to determine the Maximum Tolerated Dose (MTD) and select the recommended Phase 2 dose (RP2D). Dose escalation follows a conventional 3+3 design; successive cohorts of 3 to 6 participants each will be evaluated in sequential escalating doses of single-agent IMGC936. Upon completion of the dose-escalation phase of the study, following determination of the RP2D, up to 5 expansion cohorts may be opened in tumor types selected from those enrolled in dose escalation.

Participants with relapsed or refractory, unresectable locally advanced or metastatic solid tumors including non-squamous non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), colorectal cancer (CRC), gastroesophageal cancer, or pancreatic cancer will be enrolled.

IMGC936 is administered via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter, at the assigned dose for each cohort during dose escalation, and at the RP2D for expansion. Infusion duration will vary depending on dose and participant tolerability.

Sentinel dosing will be used for the first 2 dose levels of dose escalation. The first administration of IMGC936 in participants at the first 2 dose levels of dose escalation will be staggered by at least 48 hours. The dose-limiting toxicity (DLT) evaluation period is 21 days. Participants may continue on study drug until disease progression, adverse event (AE) requiring discontinuation, DLT during evaluation window, pregnancy, death, investigator decision, lost to follow up (LTFU), major protocol deviation requiring discontinuation, withdrawal of consent, or sponsor, investigator or regulatory agency terminates the study.

Tumor assessments are performed every 6 weeks (Q6W) while on study drug then every 12 weeks (Q12W). Tumor assessments continue until discontinuation criteria are met. If feasible, participants who discontinue study drug for reasons other than progressive disease (PD) (e.g., toxicity) should continue to undergo tumor assessments Q12W as post-treatment follow up until evidence of PD, initiation of another anticancer therapy, withdrawal of consent, LTFU, death, or end of study. Post-treatment follow up also includes following ongoing treatment emergent adverse events (TEAEs) until the event has resolved to baseline grade, the event is assessed by the investigator as stable, initiations of another anticancer therapy, withdrawal of consent, LTFU, death, or it has been determined that study drug or participation is not the cause of the AE.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dose Escalation - Schedule A: IMGC936 0.5 mg/kg	Experimental	Participants received IMGC936 0.5 milligrams (mg)/kilogram (kg) via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.	Drug: IMGC936
Dose Escalation - Schedule A: IMGC936 1.0 mg/kg	Experimental	Participants received IMGC936 1.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.	Drug: IMGC936
Dose Escalation - Schedule A: IMGC936 2.0 mg/kg	Experimental	Participants received IMGC936 2.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.	Drug: IMGC936
Dose Escalation - Schedule A: IMGC936 4.0 mg/kg	Experimental	Participants received IMGC936 4.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.	Drug: IMGC936
Dose Escalation - Schedule A: IMGC936 5.0 mg/kg	Experimental	Participants received IMGC936 5.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IMGC936	Drug	Antibody Drug Conjugate	Dose Escalation - Schedule A: IMGC936 0.5 mg/kg Dose Escalation - Schedule A: IMGC936 1.0 mg/kg Dose Escalation - Schedule A: IMGC936 2.0 mg/kg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dose Escalation Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AEs (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as any AEs with onset date between the first dose of IMGC936 and date of the last dose of IMGC936 + 30 days (inclusive) or date of the first anti-cancer therapy, whichever was earlier. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.	Up to approximately 3 years
Dose Escalation Phase: Number of Participants With Dose-limiting Toxicities (DLTs) Based on National Cancer Institute (NCI) Common Terminology Criteria for AEs Version 5.0 (CTCAE v5.0)	DLTs were defined based on TEAEs or abnormal laboratory values that met DLT criteria. Hematologic DLT: Grade 4 neutropenia lasting >7 days; ≥Grade 3 febrile neutropenia Grade 4 thrombocytopenia; Grade 3 thrombocytopenia associated with bleeding; ≥Grade 3 hemolysis. Non-hematologic DLT: Any ≥Grade 3 non-hematologic event, including Grade 3 ocular symptoms and signs; Grade 2 AEs that were prolonged inordinately; • Hepatic laboratory abnormalities meeting Hy's law criteria; Eye pain or reduction in visual acuity that did not respond to topical ophthalmic therapy. Hepatic DLT: Any elevation of ≥1 transaminases >8 * upper limit of normal (ULN); Any Grade 3 elevation of ≥1 transaminases >5.0-8.0 * ULN that did not resolve to Grade 2 within 7 days and Grade 1 within 14 days; Grade 3 elevation of total bilirubin >5 * ULN; Any Grade 3 elevation of total bilirubin >3.0-5.0 * ULN that did not resolve to Grade 2 within 7 days and Grade 1 within 14 days; Any event meeting criteria for Hy's law.	Cycle 1 (21 days for Schedule A and 28 days for Schedule B)
Dose Expansion Phase: Objective Response Rate (ORR) - Percentage of Participants With Objective Response as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Secondary Outcomes

Measure	Description	Time Frame
Dose Escalation and Dose Expansion Phase: Maximum Study Drug Concentration (Cmax)		Schedule A: Cycle 1 Day 1 (C1D1), C3D1; Schedule B: C1D1, C1D15
Dose Escalation and Dose Expansion Phase: Number of Participants With Antidrug Antibodies (ADA)		Up to approximately 3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants with histologically proven, relapsed or refractory, unresectable locally advanced or metastatic non-squamous NSCLC, TNBC, CRC, gastroesophageal cancer, or pancreatic cancer for whom no therapy with demonstrated clinical benefit is available.
1. NSCLC: Participants must have been treated with 1 to 4 prior lines of systemic therapy with no more than 2 chemotherapy containing lines.
2. TNBC: Participants must have been treated with 1 to 4 prior lines of systemic therapy for metastatic disease, excluding adjuvant therapies.
3. CRC: Participants must have been treated with 1 to 3 prior lines of systemic therapy.
4. Gastroesophageal cancer: Participants must have been treated with 1 to 3 prior lines of systemic therapy.
5. Pancreatic cancer: Participants must have been treated with 1 to 3 prior lines of systemic therapy, with no more than 2 chemotherapy containing lines.
Either measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and documented by computed tomography (CT) and/or magnetic resonance imaging (MRI) obtained within 28 days of Cycle 1 Day 1 (C1D1).
- Dose escalation: Participants may have non-measurable or measurable disease
- Dose expansion: Participants must have measurable disease
Age ≥ 18 years old.
Archival formalin-fixed paraffin-embedded (FFPE) tissue must be available. Participants may undergo a fresh tumor biopsy using a low risk, medically routine procedure to obtain a specimen for testing if a tumor sample is not available.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. If ECOG performance status is an inappropriate performance measurement for participant enrollment (for example, chronically non-ambulatory), then Karnofsky performance status must be ≥ 70.
Life expectancy ≥ 12 weeks.
Acceptable laboratory parameters as follows:
- Platelet count ≥ 75 × 1000/microliter (μL) without transfusion within 28 days prior to initiation of study drug.
- Absolute neutrophil count ≥ 1.5 × 1000/μL in the absence of any growth factor support within 21days prior to initiation of study drug.
- Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 3.0 × upper limit of normal (ULN); for participants with hepatic metastases, ALT and AST ≤ 5 × ULN.
- Total bilirubin ≤ 1.5 × ULN, except participants with Gilbert's syndrome, who may enroll if the conjugated bilirubin is within normal limits.
- Estimated glomerular filtration rate (eGFR) >30 milliliters (mL)/ minute (min)/1.73 square meter (m^2) or an estimated creatinine clearance of >30 mL/min.
- Urinalysis protein and white occult blood cells within normal limits.
- Negative serum pregnancy test for females of childbearing potential (FOCBP).
FOCBP, defined as not surgically sterilized (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) and between menarche and 1-year post menopause, must have a negative serum pregnancy test performed within 72 hours prior to initiation of study drug administration. Female participants must abstain from egg donation during the study.
FOCBP and male participants with partners of FOCBP must agree to use highly effective methods of contraception, from the time of consent through 28 weeks after discontinuation of study drug administration. Male participants must abstain from sperm donation during the study.
FOCBP is not pregnant or breastfeeding, or a male participant is not expecting to father children within the projected duration of the study, starting with screening visit through 28 weeks after the last dose of study drug.

Exclusion Criteria:

Active central nervous system (CNS) disease within the last 6 months.
Active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and/or monocular vision.
Participants who had prior therapies within the specified times below:
- Systemic antineoplastic therapy at least 5 half-lives or 4 weeks (whichever is shorter) prior to initiation of study drug.
- Mediastinal or pelvic radiation therapy within 6 weeks prior to initiation of study drug administration. Palliative, limited field radiation for symptom control to soft tissues, or bone lesions within 2 weeks prior to initiation of study drug.
Participants must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities (except alopecia).
Clinically significant cardiovascular disease including but not limited to:
- Myocardial infarction or unstable angina within 6 months prior to initiation of study drug.
- Stroke or transient ischemic attack within 6 months prior to initiation of study drug.
- Current clinically significant cardiac arrhythmias, for example, atrial fibrillation that are not well controlled with optimal medical intervention.
- Current uncontrolled hypertension: systolic blood pressure > 160 millimeters of mercury (mmHg), diastolic blood pressure > 100 mmHg.
- Current congestive heart failure (New York Heart Association class III-IV).
- Current pericarditis or clinically significant pericardial effusion.
- Current myocarditis.
- Left ventricular ejection fraction (LVEF) of < 50% by scan
- QTc interval > 480 milliseconds (msec)
Clinically significant pulmonary compromise, including pneumonia, pneumonitis, or a requirement for supplemental oxygen (excluding for sleep apnea) or history of ≥ Grade 3 drug-induced or radiation pneumonitis.
Serious concurrent illness or clinically relevant active infection, including, but not limited to the following:
- Active hepatitis B or C infection (whether or not on active antiviral therapy).
- Human immunodeficiency virus infection.
- Cytomegalovirus infection.
- Active COVID-19/SARS-CoV-2 infection. While SARS-CoV-2 testing is not mandatory for study entry, testing should follow local clinical practice guidelines/standards.
- Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to initiation of study drug.
History of prior bone marrow, stem cell, or solid organ transplantation.
Second primary invasive malignancy that has not been in remission for greater than 2 years except nonmelanoma skin cancer; cervical carcinoma in situ on biopsy; or squamous intraepithelial lesion on Pap smear; localized prostate cancer (Gleason score < 6); or resected melanoma in situ.
Major trauma or major surgery within 4 weeks prior to initiation of study drug.
Any serious underlying medical or psychiatric condition that would impair the ability of the participant to receive or tolerate the planned treatment at the study site.
Known hypersensitivity to any ingredient or any excipient contained in the drug formulation
Vaccination with any live virus vaccine within 4 weeks prior to initiation of study drug. Inactivated annual influenza vaccination is allowed.

Contacts/Locations Module

Name	Affiliation	Role
CMO ImmunoGen	ImmunoGen, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
UCSD		La Jolla	California	92037	United States
Sarah Cannon Research Institute

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38182653	Derived	Park EJ, Lee CW. Soluble receptors in cancer: mechanisms, clinical significance, and therapeutic strategies. Exp Mol Med. 2024 Feb;56(1):100-109. doi: 10.1038/s12276-023-01150-6. Epub 2024 Jan 5.
35511740	Derived	Scribner JA, Hicks SW, Sinkevicius KW, Yoder NC, Diedrich G, Brown JG, Lucas J, Fuller ME, Son T, Dastur A, Hooley J, Espelin C, Themeles M, Chen FZ, Li Y, Chiechi M, Lee J, Barat B, Widjaja L, Gorlatov S, Tamura J, Ciccarone V, Ab O, McEachem KA, Koenig S, Westin EH, Moore PA, Chittenden T, Gregory RJ, Bonvini E, Loo D. Preclinical Evaluation of IMGC936, a Next-Generation Maytansinoid-based Antibody-drug Conjugate Targeting ADAM9-expressing Tumors. Mol Cancer Ther. 2022 Jul 5;21(7):1047-1059. doi: 10.1158/1535-7163.MCT-21-0915.

IPD Sharing Statement Module

No data available

No data is available for this block.

The study included a Dose Escalation and a Dose Expansion Phase.

Arm/Group Information

ID	Title	Description
FG000	Dose Escalation - Schedule A: IMGC936 0.5 mg/kg	Participants received IMGC936 0.5 milligrams (mg)/kilogram (kg) via intravenous (IV) infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.
FG001	Dose Escalation - Schedule A: IMGC936 1.0 mg/kg	Participants received IMGC936 1.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.
FG002	Dose Escalation - Schedule A: IMGC936 2.0 mg/kg	Participants received IMGC936 2.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.
FG003	Dose Escalation - Schedule A: IMGC936 4.0 mg/kg	Participants received IMGC936 4.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.
FG004	Dose Escalation - Schedule A: IMGC936 5.0 mg/kg	Participants received IMGC936 5.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.
FG005	Dose Escalation - Schedule A: IMGC936 6.0 mg/kg	Participants received IMGC936 6.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.
FG006	Dose Escalation - Schedule A: IMGC936 7.0 mg/kg	Participants received IMGC936 7.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.
FG007	Dose Escalation - Schedule B: IMGC936 2.0 mg/kg	Participants received IMGC936 2.0 mg/kg on Days 1, 8, and 15 of a 28-day cycle for the first 2 cycles. On all subsequent cycles (Cycle 3 and beyond), participants received IMGC936 3.0 mg/kg on Days 1 and 8 of a 28-day cycle.
FG008	Dose Expansion - Non-small Cell Lung Cancer (NSCLC): IMGC936 6.0 mg/kg	Participants received IMGC936 6.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.
FG009	Dose Expansion - Triple-negative Breast Cancer (TNBC): IMGC936 6.0 mg/kg	Participants received IMGC936 6.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG0003 subjects FG0013 subjects FG0023 subjects FG0033 subjects FG0043 subjects FG00510 subjects FG0069 subjects FG0073 subjects FG00813 subjects FG0096 subjects
Received at Least 1 Dose of Study Drug		FG0003 subjects FG0013 subjects FG0023 subjects FG0033 subjects
COMPLETED	Participants were considered "Completed" when discontinuation criteria were met.	FG0003 subjects FG0013 subjects FG0023 subjects FG003
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Dose Escalation - Schedule A: IMGC936 0.5 mg/kg	Participants received IMGC936 0.5 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.
BG001	Dose Escalation - Schedule A: IMGC936 1.0 mg/kg

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

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

Dose Escalation Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AEs (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as any AEs with onset date between the first dose of IMGC936 and date of the last dose of IMGC936 + 30 days (inclusive) or date of the first anti-cancer therapy, whichever was earlier. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Safety population included all participants who received at least 1 dose of study drug.

Posted

Count of Participants

Participants

Up to approximately 3 years

ID

Adverse Events Module

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	Dose Escalation - Schedule A: IMGC936 0.5 mg/kg	Participants received IMGC936 0.5 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Pericardial effusion	Cardiac disorders	MedDRA 24.0	Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
CMO, ImmunoGen	ImmunoGen, Inc	781-895-0600		clinicaltrials@immunogen.com

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 29, 2022	Dec 19, 2024	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Nov 7, 2024	Dec 19, 2024	SAP_001.pdf

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Dose Escalation - Schedule A: IMGC936 4.0 mg/kg

Dose Escalation - Schedule A: IMGC936 5.0 mg/kg

Dose Escalation - Schedule A: IMGC936 6.0 mg/kg

Dose Escalation - Schedule A: IMGC936 7.0 mg/kg

Dose Escalation - Schedule B: IMGC936 2.0 mg/kg

Dose Expansion - NSCLC: IMGC936 6.0 mg/kg

Dose Expansion - TNBC: IMGC936 6.0 mg/kg

Participants received IMGC936 1.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

EG0000 affected3 at risk

EG0010 affected3 at risk

EG0020 affected3 at risk

EG0030 affected3 at risk

EG0040 affected3 at risk

EG0050 affected10 at risk

EG0060 affected9 at risk

EG0070 affected3 at risk

EG0080 affected13 at risk

EG0091 affected6 at risk

EG0000 affected3 at risk

EG0011 affected3 at risk

EG0020 affected3 at risk

EG0031 affected3 at risk

EG0040 affected3 at risk

EG0050 affected10 at risk

EG0063 affected9 at risk

EG0070 affected3 at risk

EG0085 affected13 at risk

EG0091 affected6 at risk

No participant had response; hence, data could not be calculated.

OG003NA(NA to NA)No participant had response; hence, data could not be calculated.

OG004NA(NA to NA)No participant had response; hence, data could not be calculated.

OG005NA(NA to NA)No participant had response; hence, data could not be calculated.

OG006NA(NA to NA)No participant had response; hence, data could not be calculated.

OG007NA(NA to NA)No participant had response; hence, data could not be calculated.

OG008NA(NA to NA)No participant had response; hence, data could not be calculated.

OG009NA(NA to NA)No participant had response; hence, data could not be calculated.

OG006NA± NANot calculable due to insufficient number of valid PK parameters

OG000	Dose Escalation - Schedule A: IMGC936 0.5 mg/kg	Participants received IMGC936 0.5 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.
OG001	Dose Escalation - Schedule A: IMGC936 1.0 mg/kg	Participants received IMGC936 1.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.
OG002	Dose Escalation - Schedule A: IMGC936 2.0 mg/kg	Participants received IMGC936 2.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.
OG003	Dose Escalation - Schedule A: IMGC936 4.0 mg/kg	Participants received IMGC936 4.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.
OG004	Dose Escalation - Schedule A: IMGC936 5.0 mg/kg	Participants received IMGC936 5.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.
OG005	Dose Escalation - Schedule A: IMGC936 6.0 mg/kg	Participants received IMGC936 6.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.
OG006	Dose Escalation - Schedule A: IMGC936 7.0 mg/kg	Participants received IMGC936 7.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.
OG007	Dose Escalation - Schedule B: IMGC936 2.0 mg/kg	Participants received IMGC936 2.0 mg/kg on Days 1, 8, and 15 of a 28-day cycle for the first 2 cycles. On all subsequent cycles (Cycle 3 and beyond), participants received IMGC936 3.0 mg/kg on Days 1 and 8 of a 28-day cycle.