Ignite Creation Date:
2024-10-25 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515613
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 First in Human Study of CTIM-76 a Claudin-6 CLDN6-Directed Bispecific Antibody in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 1a1b open-label dose escalation and expansion study to evaluate the safety and efficacy of CTIM-76 study drug a humanized T cell engaging bispecific antibody targeting CLDN6 in subjects with platinum-refractoryresistant ovarian cancer PRROC and other advanced CLDN6-positive solid tumors ie testicular and endometrial
Detailed Description:
The phase 1a Dose Escalation portion of the trial will enroll subjects with platinum-resistantrefractory ovarian cancer PRROC testicular or endometrial cancer into one of approximately 9 dose escalation cohorts to assess safety tolerability and to determine the recommended dose for expansion RDE CTIM-76 is to be administered once weekly Q1W for each cycle A cycle is defined as 28 days Subjects will be dosed until documentation of disease progression unacceptable toxicity or subjectphysician decision
The phase 1b dose expansion phase will evaluate CTIM-76 in one indication PRROC endometrial or testicular at up to 2 doses n15 response evaluable subjects at each dose level This is to enable dose- and exposure-response analyses Dosing will follow the same schedule as Phase 1a A priming dose will be administered on Day 1 and the full cohort dose will be administered weekly thereafter Expansion doses for Phase 1b will be determined by Sponsor in conjunction with Safety Review Committee SRC based upon all available safety pharmacokinetic PK pharmacodynamic PD biomarker and preliminary efficacy data from Phase 1a
The selection of the recommended Phase 2 dose RP2D will be based on the totality of data from Phase 1b
The phase 1b dose expansion phase will evaluate CTIM-76 in one indication PRROC endometrial or testicular at up to 2 doses n15 response evaluable subjects at each dose level This is to enable dose- and exposure-response analyses Dosing will follow the same schedule as Phase 1a A priming dose will be administered on Day 1 and the full cohort dose will be administered weekly thereafter Expansion doses for Phase 1b will be determined by Sponsor in conjunction with Safety Review Committee SRC based upon all available safety pharmacokinetic PK pharmacodynamic PD biomarker and preliminary efficacy data from Phase 1a
The selection of the recommended Phase 2 dose RP2D will be based on the totality of data from Phase 1b
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None