Advanced Solid Tumor
Conditions
Brief summary
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ARC101 in patients with advanced cancer.
Interventions
DRUGARC101
ARC101 will be administered according to an assigned dose schedule.
Sponsors
Third Arc Bio
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Locally advanced or metastatic solid tumor ovarian, testicular or other Claudin 6+ cancers * Measurable or evaluable disease, per RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Adequate organ function
Exclusion criteria
* Active CNS involvement * Malignancy diagnosis other than the disease under study within 2 years prior to the first dose of study drug. * Presence of uncontrolled ascites * Toxicity related to prior anticancer therapy that has not returned to Grade ≤1 or baseline levels * Clinically significant pulmonary compromise * Active autoimmune disease within 12 months prior to first dose of study drug. * Female participant who is pregnant, breastfeeding, or plans to become pregnant or male participant who plans to father a child either while enrolled or within 90 days after the final administration of study drug.
Design outcomes
Primary
| Measure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK Assessment: AUC of ARC101 | During the intervention/study therapy administration, approximately 1 year on average. | Area under the plasma concentration versus time curve |
| Overall Response Rate | During the intervention/study therapy administration, approximately 1 year on average. | Percentage of participants with best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 and overall survival (OS) |
| Duration of Response | During the intervention/study therapy administration, approximately 1 year on average. | Time from first objective response to disease progression per RECIST 1.1 or death to any cause |
| PK Assessment: Cmin of ARC101 | During the intervention/study therapy administration, approximately 1 year on average. | Measurement of Minimum Observed Concentration |
| Number of anti-drug antibody (ADA) Positive Participants | During the intervention/study therapy administration, approximately 1 year on average. | Immunogenicity will be measured by the number of participants that are ADA positive. |
| PK Assessment: Cmax of ARC101 | During the intervention/study therapy administration, approximately 1 year on average. | Measurement of Maximum Observed Concentration |
| Progression-Free Survival | During the intervention/study therapy administration, approximately 1 year on average. | 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 |
| PK Assessment: Tmax of ARC101 | During the intervention/study therapy administration, approximately 1 year on average. | Measurement of Time to Reach Maximum Concentration |
Countries
Australia, Canada, Israel, United States
Contacts
CONTACTVP Clinical Operations
Outcome results
None listed