Study of IMC-P115C in Advanced PRAME-Positive Cancers

Immunocore

Status and phase

Enrolling

Phase 1

Conditions

HLA-A*02:01-positive

Cancer

PRAME Positive

Treatments

Drug: IMC-P115C

Study type

Interventional

Funder types

Industry

Identifiers

NCT07156136

2023-509767-25 (Other Identifier)

IMC-P115C-1005

Details and patient eligibility

About

Phase 1 First-in-human study of the safety and efficacy of IMC-P115C as a single agent and in combination with standard of care (SOC) agents in participants with advanced PRAME positive cancers. IMC-P115C is a half-life extended (HLE) ImmTAC targeting PRAME.

Enrollment

140 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
HLA-A*02:01-positive
Meeting PRAME-positive tumor testing requirements
Metastatic or unresectable solid tumors
Have received (or be receiving), relapsed from, be refractory to or intolerant of all therapies
Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control

Exclusion criteria

Symptomatic or untreated central nervous system metastasis
Bowel obstruction, perforation, or fistula formation within 3 months prior to the planned first dose of study treatment
Ongoing ascites or effusion requiring recent drainages
Significant ongoing toxicity from prior anticancer treatment
Out-of-range laboratory values
Clinically significant lung, heart, or autoimmune disease
Ongoing requirement for immunosuppressive treatment
Significant secondary malignancy
Hypersensitivity to study drug or excipients
Pregnant or lactating