Advanced Solid TumorPhase 1NCT06672185
ARC101 in Advanced Solid Tumors
A Phase 1 study testing ARC101 in people with Advanced Solid Tumor, run by Third Arc Bio at 13 sites in 4 countries.
Trial summary
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ARC101 in patients with advanced cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- ARC101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 13 sitesin 4 countries
- Study dates
- 5 Feb 2025to 1 Aug 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
13 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 4 countries
Canada4 sites, 4 recruiting
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Susie Lau, MD
- Recruiting
McGill University Health Centre
Montreal, Quebec, H4A 0B1
Lucy Gilbert, MD
- Recruiting
The Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2C4
Stéphanie Lheureux, MD, PhD
- Recruiting
BC Cancer Research Centre
Vancouver, British Columbia, V5Z 0B4
Christian Kollmannsberger, MD
United States3 sites
- Withdrawn
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Terminated
START Midwest
Grand Rapids, Michigan, 49546
- Withdrawn
START San Antonio, LLC.
San Antonio, Texas, 78229
Australia3 sites, 3 recruiting
- Recruiting
Cancer Research SA
Adelaide, South Australia, 5000
Meena Okera
- Recruiting
Sunshine Coast University Private Hospital
Birtinya, Queensland, 4575
Michelle Morris
- Recruiting
Cabrini Health Research
Malvern, Victoria, 3144
Prachi Bhave
Israel3 sites, 3 recruiting
- Recruiting
Rambam Medical Center
Haifa, 3109601
Ruth Perets, MD, PhD
- Recruiting
Sheba Medical Center
Ramat Gan, 52621
Ronnie Shapira, MD
- Recruiting
Sourasky Medical Center
Tel Aviv, 6423906
Ravit Geva, MD
About this study
Official title: A Phase 1 Study of ARC101 in Advanced Solid Tumors
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ARC101 in patients with advanced cancer.
- Conditions
- Advanced Solid Tumor
- Being tested
- ARC101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARC101Drug
ARC101 will be administered according to an assigned dose schedule.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Cohorts | Experimental | ARC101 will be administered in escalating doses, with each dose escalation cohort assessing toxicity 21 days after the initial dose. Receives: Drug: ARC101 |
| Dose Expansion Cohorts | Experimental | ARC101 will be administered at recommended phase 2 dose(s). Receives: Drug: ARC101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and type of dose-limiting toxicities.
Measured: Day 1-Day 21 of the first treatment cycle
Occurrence and severity of adverse events, serious adverse events and laboratory values.
Measured: Day 1 to 100 days after the last dose of study drug.
Secondary outcomes (8)
PK Assessment: Cmax of ARC101
Measurement of Maximum Observed Concentration
Measured: During the intervention/study therapy administration, approximately 1 year on average.
PK Assessment: Cmin of ARC101
Measurement of Minimum Observed Concentration
Measured: During the intervention/study therapy administration, approximately 1 year on average.
PK Assessment: Tmax of ARC101
Measurement of Time to Reach Maximum Concentration
Measured: During the intervention/study therapy administration, approximately 1 year on average.
PK Assessment: AUC of ARC101
Area under the plasma concentration versus time curve
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: During the intervention/study therapy administration, approximately 1 year on average.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start5 Feb 2025
- Primary completion1 May 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Arc Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672185
- Sponsor's protocol ID
- ARC101-P1-101
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No