Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ARC101 in patients with advanced cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation Cohorts | Experimental | ARC101 will be administered in escalating doses, with each dose escalation cohort assessing toxicity 21 days after the initial dose. |
|
| Dose Expansion Cohorts | Experimental | ARC101 will be administered at recommended phase 2 dose(s). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARC101 | Drug | ARC101 will be administered according to an assigned dose schedule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and type of dose-limiting toxicities. | Day 1-Day 21 of the first treatment cycle | |
| Occurrence and severity of adverse events, serious adverse events and laboratory values. | Day 1 to 100 days after the last dose of study drug. |
| Measure | Description | Time Frame |
|---|---|---|
| PK Assessment: Cmax of ARC101 | Measurement of Maximum Observed Concentration | During the intervention/study therapy administration, approximately 1 year on average. |
| PK Assessment: Cmin of ARC101 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| VP Clinical Operations | Contact | 267-589-9444 | clinicaltrials@thirdarcbio.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Measurement of Minimum Observed Concentration
| During the intervention/study therapy administration, approximately 1 year on average. |
| PK Assessment: Tmax of ARC101 | Measurement of Time to Reach Maximum Concentration | During the intervention/study therapy administration, approximately 1 year on average. |
| PK Assessment: AUC of ARC101 | Area under the plasma concentration versus time curve | During the intervention/study therapy administration, approximately 1 year on average. |
| Overall Response Rate | Percentage of participants with best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 and overall survival (OS) | During the intervention/study therapy administration, approximately 1 year on average. |
| Duration of Response | Time from first objective response to disease progression per RECIST 1.1 or death to any cause | During the intervention/study therapy administration, approximately 1 year on average. |
| Progression-Free Survival | PFS is defined as the time from the start of the treatment until objective disease progression per PFS is defined as the time from the start of the treatment until objective disease progression per RECIST 1.1 or death from any cause | During the intervention/study therapy administration, approximately 1 year on average. |
| Number of anti-drug antibody (ADA) Positive Participants | Immunogenicity will be measured by the number of participants that are ADA positive. | During the intervention/study therapy administration, approximately 1 year on average. |
| START Midwest | Recruiting | Grand Rapids | Michigan | 49546 | United States |
|
| START San Antonio, LLC. | Recruiting | San Antonio | Texas | 78229 | United States |
|
| Sunshine Coast University Private Hospital | Recruiting | Birtinya | Queensland | 4575 | Australia |
|
| Cancer Research SA | Recruiting | Adelaide | South Australia | 5000 | Australia |
|
| Cabrini Health Research | Recruiting | Malvern | Victoria | 3144 | Australia |
|
| BC Cancer Research Centre | Recruiting | Vancouver | British Columbia | V5Z 0B4 | Canada |
|
| The Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G 2C4 | Canada |
|
| McGill University Health Centre | Recruiting | Montreal | Quebec | H4A 0B1 | Canada |
|
| Rambam Medical Center | Recruiting | Haifa | 3109601 | Israel |
|
| Sheba Medical Center | Recruiting | Ramat Gan | 52621 | Israel |
|
| Sourasky Medical Center | Recruiting | Tel Aviv | 6423906 | Israel |
|