Study of PM54 in Combination With Immunotherapy in Adult Participants With Advanced Malignancies

Part of paid clinical trials in New York, New York.

Sponsor
PharmaMar
Study ID
NCT07644039
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Malignancies

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    Intravenous infusion.
  • PM54 — DRUG
    Intravenous infusion.

Study Details

The main purpose of the study is to evaluate the safety, tolerability and recommended dose of PM54 in combination with pembrolizumab. To assess the antitumor activity of PM54 in combination with pembrolizumab in terms of clinical benefit rate (CBR) and objective response rate (ORR) based on investigator's assessment in participants in other cohorts.

Key Dates

Start date
May 21, 2026
Status verified
Jun 2026
Primary completion
Apr 2, 2029
Completion
Apr 2, 2029

Study Design

Enrollment
119 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 (safety Run-in): PM54 + Pembrolizumab
    Participants will initially receive a low dose of PM54. If the low dose level is tolerated, PM54 will be escalated to the high dose level in combination with pembrolizumab until a suitable dose of PM54 is established or until clinical or objective disease progression, withdrawal of consent, or unacceptable or cumulative toxicity occurs.
  • Experimental: Part 2 (Dose Expansion): PM54 + Pembrolizumab
    Participants will receive recommended dose of PM54 in combination with pembrolizumab as observed in Part 1 of the study.

Primary Outcome Measure

Parts 1 and 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Treatment Discontinuation [ Time Frame: From signing of the informed consent up to 30 days after last dose (up to 3 years) ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
START New YorkNew YorkNew York11042-
START DallasFort WorthTexas76104-
NEXT HoustonHoustonTexas77054-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
NEXT DallasIrvingTexas75039-
NEXT VirginiaFairfaxVirginia22031-

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By research site
START New York· New York, NYSTART Dallas· Fort Worth, TXNEXT Houston· Houston, TXThe University of Texas MD Anderson Cancer Center· Houston, TXNEXT Dallas· Irving, TXNEXT Virginia· Fairfax, VA

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