RecruitingPhase 1/2

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

United States119 participantsStarted 2026-05-21

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Voluntarily signed and dated written informed consent, obtained before the start of any study-specific procedures.
. Adults (greater than or equal to \[\>=\]18 years or legal consenting age, per local regulations), and able to provide free and informed consent for study participation.
. Have a pathologically confirmed diagnosis of advanced malignancy.
. Have advanced disease, as defined by progressive, relapsed, or metastatic disease that is not amenable to multimodal ablative or excisional treatments with curative intent, according to international guidelines.
. Have measurable disease according to RECIST1.1 (or mRECIST v1.1 where applicable).
. Have experienced objective disease progression on or following the prior line(s) of systemic therapy, as determined either by (1) RECIST v1.1 or equivalent, or (2) by investigator's assessment of clinical progression of disease together with objective evidence of increased tumor burden even if not meeting criteria for progressive disease per RECIST v1.1 or equivalent.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Parts 1 and 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Treatment Discontinuation

Timeframe: From signing of the informed consent up to 30 days after last dose (up to 3 years)

Part 1: Number of Participants with Dose-Limiting Toxicities (DLTs)

Timeframe: Cycle 1 (each cycle is of 21 days)

Part 2: Clinical Benefit Rate

Timeframe: up to 12 weeks

Part 2: Objective Response Rate

Timeframe: Baseline up to 3 years

Trial details

NCT IDNCT07644039

SponsorPharmaMar

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-04-02

Contact for this trial

Cristian Fernandez, M.D.

0034 91 846 6077 cmfernandez@pharmamar.com

View on ClinicalTrials.gov More Advanced Malignancies trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Voluntarily signed and dated written informed consent, obtained before the start of any study-specific procedures.
. Adults (greater than or equal to \[\>=\]18 years or legal consenting age, per local regulations), and able to provide free and informed consent for study participation.
. Have a pathologically confirmed diagnosis of advanced malignancy.
. Have advanced disease, as defined by progressive, relapsed, or metastatic disease that is not amenable to multimodal ablative or excisional treatments with curative intent, according to international guidelines.
. Have measurable disease according to RECIST1.1 (or mRECIST v1.1 where applicable).
. Have experienced objective disease progression on or following the prior line(s) of systemic therapy, as determined either by (1) RECIST v1.1 or equivalent, or (2) by investigator's assessment of clinical progression of disease together with objective evidence of increased tumor burden even if not meeting criteria for progressive disease per RECIST v1.1 or equivalent.

What they're measuring

Parts 1 and 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Treatment Discontinuation

Timeframe: From signing of the informed consent up to 30 days after last dose (up to 3 years)

Part 1: Number of Participants with Dose-Limiting Toxicities (DLTs)

Timeframe: Cycle 1 (each cycle is of 21 days)

Part 2: Clinical Benefit Rate

Timeframe: up to 12 weeks

Part 2: Objective Response Rate

Timeframe: Baseline up to 3 years

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria