Recruiting nowPhase 1
What this trial is trying to do
The researchers are testing whether adding the investigational drug PLN-101095 to pembrolizumab can be given safely to people whose advanced or metastatic cancer has progressed during or after pembrolizumab. The trial will establish suitable doses and look for early signs that the combination controls the cancer.
The idea is that continuing pembrolizumab with PLN-101095 might produce tumour control after pembrolizumab alone has stopped working. In this early trial, the main measure is safety and tolerability; tumour responses are only preliminary signals, not evidence of longer survival or longer control.
Worth knowing: This is a small, open-label, non-randomised phase 1 trial, so it is mainly testing safety and dose rather than comparing the combination with another treatment.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT06270706 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | not randomised, open label |
| Taking part | 124 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Pliant Therapeutics, Inc. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug PLN-101095
- Drug Pembrolizumab
What it is measuring
Safety and tolerability of PLN-101095 in combination with pembrolizumab in Parts 1 and 2
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 1. Tests safety and dose in a small group. Some people do benefit, but that is not what the trial is designed to find out.
How the researchers describe it
This is a Phase 1a/1b, dose-escalation/expansion, consecutive-cohort, open-label study to evaluate the safety, tolerability, PK, PD, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab (the study treatment regimen) in adult participants with advanced or metastatic solid tumors for which pembrolizumab is indicated but have documented disease progression (refractory [primary resistance]) or relapsed [secondary resistance]) after at least 3 months from the start of treatment with pembrolizumab.
The study will consist of 2 main parts:
* Part 1: Consecutive dose-escalation cohorts using a Bayesian optimal interval (BOIN) dose escalation design with accelerated titration
* Part 2: Dose-expansion cohorts using Simon's 2-stage designWritten by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
1. Has histologically or cytologically confirmed advanced or metastatic solid tumor
2. Have received ≥12 weeks of continuous anti-PD-1 or anti-PD-L1 treatment administered as monotherapy or in combination with other anticancer therapies
3. Have demonstrated documented prior clinical benefit, defined as CR or PR at any time during treatment, or SD lasting ≥6 months (Part 2 only)
4. Must have subsequently developed radiographic disease progression while receiving anti-PD-1 or anti-PD-L1 treatment or within ≤12 weeks after the last dose of such treatment
5. At least 1 measurable lesion, as defined by RECIST v1.1
6. Estimated survival of ≥3 months
7. Have adequate bone marrow and organ function.
8. A female participant is eligible to participate if she is not pregnant, not breastfeeding
Exclusion Criteria
1. Any immune-related medical conditions that would put participants at greater risk when receiving pembrolizumab
2. Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
3. Has received prior radiotherapy within 2 weeks for palliative bone-directed therapy and 4 weeks for all other radiotherapy
4. Has undergone major surgery within 4 weeks prior to the first dose of study treatment or has not adequately recovered from surgery or related complications
5.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 12 sites. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
- This trial recruits across several cancer types rather than being designed around bowel cancer. Is there evidence it does anything in mine?
The source
Registry record NCT06270706, registered by Pliant Therapeutics, Inc. on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.