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An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is a Phase 1a/1b, open-label, multicenter dose escalation and dose expansion clinical study to evaluate the safety, PK, immunogenicity and preliminary efficacy of IDE034 in participants with locally advanced/metastatic solid tumor types that express B7-H3 and PTK7.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participant must be at least 18 years of age or the age of maturity per local regulations

• Participants with advanced recurrent or metastatic solid tumors expressing B7-H3 and PTK7 in the following indications: NSCLC, ESCC, endometrial cancer, HGSOC, HNSCC, TNBC (estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 \[HER2\] negative), CRC, and CRPC who have radiologically progressed or recurred on at least one line of therapy or is intolerant to additional effective standard therapies.

• Archival tissue sample for testing

• Measurable disease

• Have Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.

• Have adequate bone marrow and organ function.

• Able to comply with contraceptive/barrier requirements

Locations
United States
Texas
NEXT Texas LLC - Austin
RECRUITING
Austin
NEXT Texas LLC - Houston
RECRUITING
Houston
NEXT Texas LLC - Dallas
RECRUITING
Irving
NEXT Texas LLC - San Antonio
RECRUITING
San Antonio
Virginia
NEXT Texas LLC - Virginia
RECRUITING
Fairfax
Time Frame
Start Date: 2026-02-24
Estimated Completion Date: 2027-07-30
Participants
Target number of participants: 150
Treatments
Experimental: Part 1:IDE034 Dose Escalation
IDE034 Dose Escalation Successive cohorts of participants will be treated with increasing doses of IDE034 until the maximum tolerated dose or the recommended dose for expansion is determined
Experimental: Part 2: IDE034 Dose Expansion
IDE034 Dose Expansion To further assess the safety, tolerability, and preliminary antitumor activity at one or more dose levels of IDE034 selected from dose escalation
Sponsors
Leads: IDEAYA Biosciences

This content was sourced from clinicaltrials.gov