Advanced or Metastatic Solid TumorPhase 1NCT06270706
A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors
A Phase 1 study testing PLN-101095 and Pembrolizumab in people with Advanced or Metastatic Solid Tumor, run by Pliant Therapeutics, Inc. at 22 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumor
- What is being tested?
- PLN-101095 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 30 Aug 2023to Jun 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has histologically or cytologically confirmed advanced or metastatic solid tumor
- Have received ≥12 weeks of continuous anti-PD-1 or anti-PD-L1 treatment administered as monotherapy or in combination with other anticancer therapies
- Have demonstrated documented prior clinical benefit, defined as CR or PR at any time during treatment, or SD lasting ≥6 months (Part 2 only)
- 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
- At least 1 measurable lesion, as defined by RECIST v1.1
- Estimated survival of ≥3 months
- Have adequate bone marrow and organ function.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding
Who cannot join
- Any immune-related medical conditions that would put participants at greater risk when receiving pembrolizumab
- Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
- Has received prior radiotherapy within 2 weeks for palliative bone-directed therapy and 4 weeks for all other radiotherapy
- 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
- Has a diagnosis of immunodeficiency or use of systemic steroids >10 mg/day
- Has an active autoimmune disease that has required systemic treatment in the past 2 years
Show all 10Show fewer
- Has known active CNS metastases (brain and/or leptomeningeal metastases)
- Has significant cardiac disease
- Has an active infection requiring systemic therapy (including uncontrolled HIV, Hepatitis B and C)
- 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
Trial locations and contacts
22 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 2 countries
United States16 sites, 15 recruiting
- Recruiting
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Pliant Therapeutics Medical Monitor, clintrials@pliantrx.com
- Recruiting
NEXT Austin
Austin, Texas, 78758
Pliant Therapeutics Medical Monitor, clintrials@pliantrx.com
- Recruiting
START New Jersey
East Brunswick, New Jersey, 08816
Pliant Therapeutics Medical Monitor, clintrials@pliantrx.com
- Recruiting
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Pliant Therapeutics Medical Monitor, clintrials@pliantrx.com
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
Pliant Therapeutics Medical Monitor, clintrials@pliantrx.com
- Recruiting
START Center for Clinical Research
Fort Worth, Texas, 76104
Pliant Therapeutics Medical Monitor, clintrials@pliantrx.com
- Recruiting
South Texas Accelerated Research Therapeutics (START)
Grand Rapids, Michigan, 49546
Pliant Therapeutics Medical Monitor, clintrials@pliantrx.com
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Pliant Therapeutics Medical Monitor, clintrials@pliantrx.com
- Recruiting
NEXT Houston
Houston, Texas, 77054
Pliant Therapeutics Medical Monitor, clintrials@pliantrx.com
- Recruiting
START New York Long Island LLC
Lake Success, New York, 11042
Pliant Therapeutics Medical Monitor, clintrials@pliantrx.com
- Recruiting
Tennessee Oncology
Nashville, Tennessee, 37203
Pliant Therapeutics Medical Monitor, clintrials@pliantrx.com
- Completed
Yale University
New Haven, Connecticut, 06511
- Recruiting
Avera Medical Group
Sioux Falls, South Dakota, 57105
Pliant Therapeutics Medical Monitor, clintrials@pliantrx.com
- Recruiting
Washington University Medicine
St Louis, Missouri, 63110
Pliant Therapeutics Medical Monitor, clintrials@pliantrx.com
- Recruiting
START Mountain Region
West Valley City, Utah, 84119
Pliant Therapeutics Medical Monitor, clintrials@pliantrx.com
- Recruiting
Carolina Cancer Research Center
Wilson, North Carolina, 27893
Pliant Therapeutics Medical Monitor, clintrials@pliantrx.com
Spain6 sites, 6 recruiting
- Recruiting
Hospital Universitari Quirónsalud (NEXT Barcelona)
Barcelona, Barcelona, 08023
Pliant Therapeutics Medical Monitor, clintrials@pliantrx.com
- Recruiting
START Barcelona - Hospital HM Nou Delfos
Barcelona, Barcelona, 08023
Pliant Therapeutics Medical Monitor, clintrials@pliantrx.com
- Recruiting
START Center for Cancer Research - La Rioja
Logroño, La Rioja, 26006
Pliant Therapeutics Medical Monitor, clintrials@pliantrx.com
- Recruiting
START Madrid - Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, 28040
Pliant Therapeutics Medical Monitor, clintrials@pliantrx.com
- Recruiting
START Madrid - Centro Integral Oncológico Clara Campal
Madrid, Madrid, 28050
Pliant Therapeutics Medical Monitor, clintrials@pliantrx.com
- Recruiting
University Hospital Quironsalud Madrid (NEXT Madrid)
Madrid, Pozuelo de Alarcón, 28223
Pliant Therapeutics Medical Monitor, clintrials@pliantrx.com
About this study
Official title: A Phase 1a/1b Multicenter, Open-label Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of PLN-101095 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Advanced or Metastatic Solid Tumors Who Have Disease Progression While on an Immune Checkpoint Inhibitor (FORTIFY)
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 design
- Conditions
- Advanced or Metastatic Solid Tumor
- Being tested
- PLN-101095, Pembrolizumab
- Keywords
- Advanced Solid Tumors Cancer, Anal Carcinoma, Biliary tract carcinoma (BTC), Cholangiocarcinoma, Clear cell renal cell carcinoma (ccRCC), Colorectal Cancer, Endometrial Cancer, Gallbladder, Head and Neck Squamous Cell Cancer (HNSCC), Melanoma, Non-small cell lung cancer (NSCLC), Ovarian Carcinoma, Triple Negative Breast Cancer (TNBC), Tumor mutational burden (TMB)-high tumors, TMB-low tumors, Urothelial Carcinoma, Pembrolizumab, Immunotherapy
- Medical subject headings
- Neoplasm Metastasis, Anus Neoplasms, Cholangiocarcinoma, Carcinoma, Renal Cell, Colorectal Neoplasms, Endometrial Neoplasms, Melanoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLN-101095Drug
PLN-101095 250 mg BID
PLN-101095Drug
PLN-101095 500 mg BID
PLN-101095Drug
PLN-101095 1000 mg BID
PLN-101095Drug
PLN-101095 1000 mg TID
PLN-101095Drug
PLN-101095 2000 mg BID
PLN-101095Drug
PLN-101095
PembrolizumabDrug
Pembrolizumab (KEYTRUDA) 200 mg IV Q3W
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Dose Escalation - 250 mg BID | Experimental | Cohort 1 PLN-101095 250 mg BID in combination with pembrolizumab in participants with solid tumors Receives: Drug: PLN-101095; Drug: Pembrolizumab |
| Part 1 Dose Escalation - 500 mg BID | Experimental | PLN-101095 500 mg BID in combination with pembrolizumab in participants with solid tumors Receives: Drug: PLN-101095; Drug: Pembrolizumab |
| Part 1 Dose Escalation - 1000 mg BID | Experimental | PLN-101095 1000 mg BID in combination with pembrolizumab in participants with solid tumors Receives: Drug: PLN-101095; Drug: Pembrolizumab |
| Part 1 Dose Escalation - 1000 mg TID | Experimental | PLN-101095 1000 mg TID in combination with pembrolizumab in participants with solid tumors Receives: Drug: PLN-101095; Drug: Pembrolizumab |
| Part 1 Dose Escalation - 2000 mg BID | Experimental | PLN-101095 2000 mg BID in combination with pembrolizumab in participants with solid tumors Receives: Drug: PLN-101095; Drug: Pembrolizumab |
| Part 2 Dose Expansion - NSCLC | Experimental | PLN-101095 given as monotherapy and in combination with pembrolizumab in participants with Non-small cell lung cancer (NSCLC) Receives: Drug: PLN-101095; Drug: Pembrolizumab |
| Part 2 Dose Expansion - ccRCC | Experimental | PLN-101095 given as monotherapy and in combination with pembrolizumab in participants with Clear cell renal cell carcinoma (ccRCC) Receives: Drug: PLN-101095; Drug: Pembrolizumab |
| Part 2 Dose Expansion - TMB-high solid tumors | Experimental | PLN-101095 given as monotherapy and in combination with pembrolizumab in participants with Tumor mutational burden (TMB)-high solid tumors Receives: Drug: PLN-101095; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of PLN-101095 in combination with pembrolizumab in Parts 1 and 2
Number of participants with a Dose Limiting Toxicity (DLT) defined as toxicities that meet predefined severity criteria, assess as having a suspected relationship to study drug, unrelated to disease, inter-current illness, or concomitant medications.
Measured: First dose to 35 days
Safety and tolerability of PLN-101095 in combination with pembrolizumab in Parts 1 and 2
Proportion of participants with treatment-emergent adverse events and serious adverse events.
Measured: Day 1 until 16 weeks after end of study treatment regimen
Anti-tumor activity of PLN-101095 in combination with pembrolizumab in Part 2
Proportion of participants achieving confirmed iPR or iCR per iRECIST Version 1.1.
Measured: First dose to disease progression or death from any cause, whichever occurs first.
Anti-tumor activity of PLN-101095 in combination with pembrolizumab in Part 2
Proportion of participants who maintain disease control (iCR, iPR or iSD) per iRECIST Version 1.1.
Measured: First dose to disease progression or death from any cause, whichever occurs first.
Secondary outcomes (5)
PK of PLN-101095 monotherapy in Parts 1 and 2
Maximum drug concentration (Cmax)
Measured: Day 14, 0 to up to 12 hours
PK of PLN-101095 monotherapy in Parts 1 and 2
Time to Cmax (Tmax)
Measured: Day 14, 0 to up to 12 hours
PK of PLN-101095 monotherapy in Parts 1 and 2
Area under the concentration-time curve (AUC0-τ)
Measured: Day 14, 0 to up to 12 hours
Duration of anti-tumor activity of PLN-101095 in combination with pembrolizumab in Part 2
Duration of response (DOR) for objective responders
Measured: First objective response (CR or PR) to disease progression or death from any cause, whichever occurs first
Duration of anti-tumor activity of PLN-101095 in combination with pembrolizumab in Part 2
Time on treatment (TOT) for objective responders
Measured: First dose to progression or death from any cause, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start30 Aug 2023
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pliant Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pliant Therapeutics Medical Monitor, Study director, Pliant Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270706
- Sponsor's protocol ID
- PLN-101095-ONC-101
- Status last verified
- Sep 2026
- First submitted
- 26 Jan 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b Multicenter, Open-label Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of PLN-101095 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Advanced or Metastatic Solid Tumors Who Have Disease Progression While on an Immune Checkpoint Inhibitor (FORTIFY)
- ClinicalTrials.gov ID
- NCT06270706
- Acronym / sponsor ID
- PLN-101095-ONC-101
- Conditions
- Advanced or Metastatic Solid Tumor
- Keywords
- Advanced Solid Tumors Cancer, Anal Carcinoma, Biliary tract carcinoma (BTC), Cholangiocarcinoma, Clear cell renal cell carcinoma (ccRCC), Colorectal Cancer, Endometrial Cancer, Gallbladder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Pliant Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1 Dose Escalation - 250 mg BID | Experimental | Drug: PLN-101095, Drug: PembrolizumabCohort 1 PLN-101095 250 mg BID in combination with pembrolizumab in participants with solid tumors |
| Part 1 Dose Escalation - 500 mg BID | Experimental | Drug: PLN-101095, Drug: PembrolizumabPLN-101095 500 mg BID in combination with pembrolizumab in participants with solid tumors |
| Part 1 Dose Escalation - 1000 mg BID | Experimental | Drug: PLN-101095, Drug: PembrolizumabPLN-101095 1000 mg BID in combination with pembrolizumab in participants with solid tumors |
| Part 1 Dose Escalation - 1000 mg TID | Experimental | Drug: PLN-101095, Drug: PembrolizumabPLN-101095 1000 mg TID in combination with pembrolizumab in participants with solid tumors |
| Part 1 Dose Escalation - 2000 mg BID | Experimental | Drug: PLN-101095, Drug: PembrolizumabPLN-101095 2000 mg BID in combination with pembrolizumab in participants with solid tumors |
| Part 2 Dose Expansion - NSCLC | Experimental | Drug: PLN-101095, Drug: PembrolizumabPLN-101095 given as monotherapy and in combination with pembrolizumab in participants with Non-small cell lung cancer (NSCLC) |
| Part 2 Dose Expansion - ccRCC | Experimental | Drug: PLN-101095, Drug: PembrolizumabPLN-101095 given as monotherapy and in combination with pembrolizumab in participants with Clear cell renal cell carcinoma (ccRCC) |
| Part 2 Dose Expansion - TMB-high solid tumors | Experimental | Drug: PLN-101095, Drug: PembrolizumabPLN-101095 given as monotherapy and in combination with pembrolizumab in participants with Tumor mutational burden (TMB)-high solid tumors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Has histologically or cytologically confirmed advanced or metastatic solid tumor
- Have received ≥12 weeks of continuous anti-PD-1 or anti-PD-L1 treatment administered as monotherapy or in combination with other anticancer therapies
- Have demonstrated documented prior clinical benefit, defined as CR or PR at any time during treatment, or SD lasting ≥6 months (Part 2 only)
- 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
- At least 1 measurable lesion, as defined by RECIST v1.1
Key exclusion criteria (10 listed)
- Any immune-related medical conditions that would put participants at greater risk when receiving pembrolizumab
- Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
- Has received prior radiotherapy within 2 weeks for palliative bone-directed therapy and 4 weeks for all other radiotherapy
- 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
- Has a diagnosis of immunodeficiency or use of systemic steroids >10 mg/day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLN-101095PLN-101095 250 mg BID | Drug | Part 1 Dose Escalation - 250 mg BID |
| PLN-101095PLN-101095 500 mg BID | Drug | Part 1 Dose Escalation - 500 mg BID |
| PLN-101095PLN-101095 1000 mg BID | Drug | Part 1 Dose Escalation - 1000 mg BID |
| PLN-101095PLN-101095 1000 mg TID | Drug | Part 1 Dose Escalation - 1000 mg TID |
| PLN-101095PLN-101095 2000 mg BID | Drug | Part 1 Dose Escalation - 2000 mg BID |
| PLN-101095PLN-101095 | Drug | Part 2 Dose Expansion - NSCLC, Part 2 Dose Expansion - TMB-high solid tumors, Part 2 Dose Expansion - ccRCC |
| PembrolizumabPembrolizumab (KEYTRUDA) 200 mg IV Q3W | Drug | Part 1 Dose Escalation - 1000 mg BID, Part 1 Dose Escalation - 1000 mg TID, Part 1 Dose Escalation - 2000 mg BID, Part 1 Dose Escalation - 250 mg BID, Part 1 Dose Escalation - 500 mg BID, Part 2 Dose Expansion - NSCLC, Part 2 Dose Expansion - TMB-high solid tumors, Part 2 Dose Expansion - ccRCC |
Primary outcome
Safety and tolerability of PLN-101095 in combination with pembrolizumab in Parts 1 and 2
Time frame: First dose to 35 days
Number of participants with a Dose Limiting Toxicity (DLT) defined as toxicities that meet predefined severity criteria, assess as having a suspected relationship to study drug, unrelated to disease, inter-current illness, or concomitant medications.
Safety and tolerability of PLN-101095 in combination with pembrolizumab in Parts 1 and 2
Time frame: Day 1 until 16 weeks after end of study treatment regimen
Proportion of participants with treatment-emergent adverse events and serious adverse events.
Anti-tumor activity of PLN-101095 in combination with pembrolizumab in Part 2
Time frame: First dose to disease progression or death from any cause, whichever occurs first.
Proportion of participants achieving confirmed iPR or iCR per iRECIST Version 1.1.
Anti-tumor activity of PLN-101095 in combination with pembrolizumab in Part 2
Time frame: First dose to disease progression or death from any cause, whichever occurs first.
Proportion of participants who maintain disease control (iCR, iPR or iSD) per iRECIST Version 1.1.
5 secondary outcomes
PK of PLN-101095 monotherapy in Parts 1 and 2
Time frame: Day 14, 0 to up to 12 hours
PK of PLN-101095 monotherapy in Parts 1 and 2
Time frame: Day 14, 0 to up to 12 hours
PK of PLN-101095 monotherapy in Parts 1 and 2
Time frame: Day 14, 0 to up to 12 hours
Duration of anti-tumor activity of PLN-101095 in combination with pembrolizumab in Part 2
Time frame: First objective response (CR or PR) to disease progression or death from any cause, whichever occurs first
Duration of anti-tumor activity of PLN-101095 in combination with pembrolizumab in Part 2
Time frame: First dose to progression or death from any cause, whichever occurs first
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pliant Therapeutics Medical Monitor study director
Pliant Therapeutics, Inc.
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PLN-101095 and Pembrolizumab in people with Advanced or Metastatic Solid Tumor, run by Pliant Therapeutics, Inc. at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pliant Therapeutics Medical Monitor (clintrials@pliantrx.com, clintrials@pliantrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of PLN-101095 in combination with pembrolizumab in Parts 1 and 2 (time frame: First dose to 35 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.