Health TrialsbyHealthPanel

Study of IMC-P115C in Advanced PRAME-Positive Cancers

ConditionsPRAME PositiveCancerHLA-A*02:01-positive
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorImmunocore Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • IMC-P115C

    Drug

    IV infusion

Treatment groups

140 Participants
are divided into 1 treatment group
Group A: Arm A: IMC-P115C MonotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of participants with dose-limiting toxicities (DLT)

Time frame
Up to ~16 months
2

Percentage of participants with adverse events (AE)

Time frame
Up to ~16 months
3

Percentage of participants with serious adverse events (SAE)

Time frame
Up to ~16 months
4

Percentage of participants with a dose interruption, reduction, or discontinuation

Percentage of participants with dosing changes or discontinuations.

Time frame
Up to ~16 months

Secondary outcomes

1

Best Overall Response (BOR) as determined by RECIST v1.1 per the Investigator.

Time frame
Up to ~19 months
2

Duration of Response (DOR) as determined by RECIST v1.1 per the Investigator.

Time frame
Up to ~19 months
3

Progression Free Survival (PFS) as determined by RECIST v1.1 per the Investigator.

Time frame
Up to ~19 months
4

Overall Survival (OS)

OS is the time from first dose of study therapy until death due to any cause.

Time frame
Up to ~19 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Immunocore Ltd

Lead sponsor

Source ClinicalTrials.gov
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