Testing PLN-101095 with pembrolizumab in adults with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 study evaluates the safety and effectiveness of PLN-101095 in combination with pembrolizumab for adults with advanced or metastatic solid tumors that have progressed after pembrolizumab treatment. The study consists of two parts: a dose-escalation phase to determine the optimal dose using a Bayesian design, followed by a dose-expansion phase to assess preliminary antitumor activity. Participants must have measurable lesions and no effective treatment options available. The goal is to find a potentially effective treatment for patients who have limited choices.

Why it matters

Who can join: the full rules

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. Has a diagnosis of immunodeficiency or use of systemic steroids \>10 mg/day
6. Has an active autoimmune disease that has required systemic treatment in the past 2 years
7. Has known active CNS metastases (brain and/or leptomeningeal metastases)
8. Has significant cardiac disease
9. Has an active infection requiring systemic therapy (including uncontrolled HIV, Hepatitis B and C)
10. Has received a live or live-attenuated vaccine within 30 days or a non-live vaccine within 7 days prior to the first dose of PLN-101095

Where it's running

• Winship Cancer Institute of Emory University
  Atlanta, Georgia, United States Recruiting
• South Texas Accelerated Research Therapeutics (START)
  Grand Rapids, Michigan, United States Recruiting
• Washington University Medicine
  St Louis, Missouri, United States Recruiting
• START New Jersey
  East Brunswick, New Jersey, United States Recruiting
• START New York Long Island LLC
  Lake Success, New York, United States Recruiting
• Carolina Cancer Research Center
  Wilson, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Pliant Therapeutics Medical Monitor
• Email: clintrials@pliantrx.com
• Phone: clintrials@pliantrx.com

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.