Clinical trial NCT06672185: ARC101 in Advanced Solid Tumors
Official title: A Phase 1 Study of ARC101 in Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Third Arc Bio
Sponsor class: INDUSTRY
First posted: 2024-11-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ARC101 in patients with advanced cancer.


Eligibility criteria: 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.

Primary outcomes:
measure: Frequency and type of dose-limiting toxicities.
timeFrame: Day 1-Day 21 of the first treatment cycle
measure: Occurrence and severity of adverse events, serious adverse events and laboratory values.
timeFrame: Day 1 to 100 days after the last dose of study drug.
Secondary outcomes:
measure: PK Assessment: Cmax of ARC101
timeFrame: During the intervention/study therapy administration, approximately 1 year on average.
measure: PK Assessment: Cmin of ARC101
timeFrame: During the intervention/study therapy administration, approximately 1 year on average.
measure: PK Assessment: Tmax of ARC101
timeFrame: During the intervention/study therapy administration, approximately 1 year on average.
measure: PK Assessment: AUC of ARC101
timeFrame: During the intervention/study therapy administration, approximately 1 year on average.
measure: Overall Response Rate
timeFrame: During the intervention/study therapy administration, approximately 1 year on average.
measure: Duration of Response
timeFrame: During the intervention/study therapy administration, approximately 1 year on average.
measure: Progression-Free Survival
timeFrame: During the intervention/study therapy administration, approximately 1 year on average.
measure: Number of anti-drug antibody (ADA) Positive Participants
timeFrame: During the intervention/study therapy administration, approximately 1 year on average.
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: START Midwest
state: Michigan
city: San Antonio
country: United States
facility: START San Antonio, LLC.
state: Texas
city: Birtinya
country: Australia
facility: Sunshine Coast University Private Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Cancer Research SA
state: South Australia
city: Malvern
country: Australia
facility: Cabrini Health Research
state: Victoria
Study officials:
References: