Gotistobart Long Term Extension (LTE) Study

Sponsor
OncoC4, Inc.
Study ID
NCT07659379
Phase
PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gotistobart — DRUG
    ONC-392 will be given following parent trial

Study Details

This LTE study will examine the long-term overall survival and safety of gotistobart in patients with advanced solid tumors.

Key Dates

First listed
Jun 22, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Jul 1, 2036
Completion
Jan 1, 2037

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • No Intervention: Cohort A: survival follow up period of the parent trial
    Participants enrolling in Cohort A of the trial are those who, upon rolling over into this LTE study, are in the survival follow up period of the parent trial. Participants who discontinue study treatment in parent trial should be encouraged to roll over to this LTE for longer survival follow up through periodic clinical visits or telemedicine visits.
  • Experimental: Cohort B: receive the study treatment specified in the parent trial
    Participants enrolling in Cohort B are those who, upon rolling over into this LTE study, are determined to derive clinical benefit from continued study treatment. These participants will continue to receive the study treatment specified in the parent trial, with gotistobart or an gotistobart-based combination, until one of the following occurs.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: 240 months ]

Related Studies