Locally Advanced or Metastatic Solid TumorsPhase 1/2NCT06244992
PTT-936 Alone or in Combination in Patients With Locally Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing PTT-936 and Combination of PTT-936 and anti-PD-1/L1 therapy in people with Locally Advanced or Metastatic Solid Tumors, run by Pyrotech Therapeutics, Inc. at 6 sites in 2 countries.
Trial summary
This Phase 1/2a study will explore the safety and efficacy of PTT-936, an Alpha Kinase 1 (ALPK1) activator, used alone or in combination with anti-PD-1/L1 therapy in patients with locally advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Solid Tumors
- What is being tested?
- PTT-936 and Combination of PTT-936 and anti-PD-1/L1 therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 26 Jan 2024to 31 Dec 2027
- Phase
- Phase 1/2
- 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
- Voluntarily signed informed consent form (ICF).
- Ability and willingness to adhere to all study procedures.
- Male or female patients ≥ 18 years of age at the time of signing the ICF.
- Locally advanced unresectable or metastatic solid tumor confirmed by histology or cytology
- For Part A: On tumor imaging, as assessed by RECIST v1.1 and iRECIST, with measurable or unmeasurable disease. For Part B: On tumor imaging, as assessed by RECIST v1.1 and iRECIST, with at least one measurable disease.
- Life expectancy ≥ 3 months.
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- Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1 for Part A and Part B.
- Adequate end-organ and hematopoietic function, defined based on the following laboratory results obtained within 7 days prior to the first dose of study treatment [Day 1]):
- Absolute neutrophil count (ANC) ≥ 1.5×109/L (1500/μL), without granulocyte colony-stimulating factor (G-CSF) support. Note that G-CSF may be administered until 14 days prior to Cycle 1 Day 1 (C1D1).
- Platelet count ≥ 90×109/L (90,000/μL) without transfusion within 14 days prior to C1D1.
- Hemoglobin ≥ 90 g/L (9 g/dL). Note that patients may be transfused or receive erythropoietic treatment to meet this criterion until 14 days prior to C1D1.
- Creatinine clearance ≥ 60 mL/min.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x the upper limit of normal (ULN) with or without primary or metastatic liver tumor lesions.
- Total bilirubin (TBIL) ≤ 1.5 x ULN.
- For patients not receiving therapeutic anticoagulation: International Normalized Ratio (INR), activated partial thromboplastin time (aPTT) and prothrombin time (PT) ≤ 1.5 x ULN.
- For patients receiving warfarin: INR ≤ 3.0 x ULN and no bleeding within 14 days prior to Day 1. Patients receiving therapeutic anticoagulation must be on a stable dose for a minimum of 14 days prior to Day 1. Patients on low molecular weight heparin will be allowed.
Who cannot join
- Patients with leptomeningeal (LMD) metastases or patients with new and/or progressive brain metastases at the time of study entry. Patients with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after central nervous system (CNS)-directed treatment (radiotherapy and/or surgery), as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period.
- History of primary malignancy other than the diseases under study, not in remission greater than three (3) years prior to Day 1. Exceptions that do not require a 3-year remission include: adequately treated non-melanoma skin cancer, cervical carcinoma in situ on biopsy or squamous intraepithelial lesion on Papanicolaou (PAP) smear, in situ prostate cancer (with no evidence of active disease for two [2] years prior to Day 1), or resected melanoma in situ and radically resected papillary thyroid carcinoma.
- Persistence of Adverse Events (AEs) from prior anti-cancer therapy that have not resolved to Grade 1 (except for alopecia and hypothyroidism), or any history of Grade ≥ 3 immune-related adverse events (irAEs), Grade ≥ 2 pneumonitis, hypophysitis or encephalitis related to immunotherapy, or other Grade ≥ 3 drug-related CNS toxicity.
- Active systemic autoimmune disease or a history of autoimmune disorder that may relapse (e.g., systemic lupus erythematosus [SLE], rheumatoid arthritis, inflammatory bowel disease [IBD], autoimmune thyroid disorder*, multiple sclerosis, vasculitis, glomerulitis, eczema, psoriasis, etc.).
- Note that primary or secondary hypothyroidism, well controlled with hormone replacement therapy is permitted.
- Major trauma or major surgery within 4 weeks prior to Day 1 or anticipated major surgery during study participation.
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- Serious unhealing wound, ulcer, or bone fracture.
- History of and/or presence of any of the following cardiovascular and cerebrovascular events or conditions:
- History of myocardial infarction, unstable or severe angina, or arterial thrombotic event (such as cerebrovascular attack [CVA] or transient ischemic attack [TIA]) within 12 months prior to Day 1.
- Significant abnormalities on the screening of ECG, including corrected QT interval (QTc interval) \> 470 msec (average of triplicate measurements, corrected for heart rate using Fridericia's formula), second degree (Mobitz type II) or third degree atrioventricular (AV) block, or other clinically significant (in the Investigator's opinion) arrhythmia.
- Current New York Heart Association (NYHA) stage II-IV congestive heart failure (CHF).
- Left ventricular ejection fraction (LVEF) \< 50%.
- Note that LVEF assessment by echocardiogram (ECHO) scan performed as part of the patient's regular care within 4 weeks prior to the screening visit may be used for confirmation of eligibility.
- Other clinically significant (in the Investigator's opinion) cardiac diseases (e.g., valvular disease, cardiomegaly, ventricular hypertrophy, cardiomyopathy, myocarditis, etc.).
- Uncontrolled hypertension (defined as a systolic blood pressure [SBP] ≥ 150 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg at screening), despite appropriate antihypertensive therapy, or poor compliance with an antihypertensive regimen.
- Active or recent (past 6 months) bleeding disorder, including gastrointestinal (GI) bleeding, as evidenced by hematemesis, significant hemoptysis, or melena within 6 months prior to Day 1.
- Uncontrolled diabetes.
- Chronic severe liver disease or Child-Pugh B or C liver cirrhosis.
- History of alcoholism or drug abuse within the past year.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
Precision NextGen Oncology and Research Center
Beverly Hills, California, 90212
Rebecca Godin, RN, BSN, (424)777-0708, RebeccaG@NextGenOnc.com
- Recruiting
D&H Cancer Research Center
Margate, Florida, 33063
Alexandar M Finol, 954-323-2422, amanzano@dhnrc.com
- Recruiting
The START Center
San Antonio, Texas, 78229
Isabel Jimenez, 210-593-5265, Isabel.Jimenez@startsa.com
China3 sites, 3 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing
Hongwu Liao, 010-88196391, liaohongwu2015@163.com
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing
Shuopeng Jia, 0316-5918495, lfcancergcp@163.com
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Ran Xu, 020-87343009, llwyh@sysucc.org.cn
About this study
Official title: A Phase 1/2a Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PTT-936, an Alpha Kinase 1 (ALPK1) Activator, Alone or in Combination With Anti-PD-1/L1 in Patients With Locally Advanced or Metastatic Solid Tumors
This Phase 1/2a study will explore the safety and efficacy of PTT-936, an Alpha Kinase 1 (ALPK1) activator, used alone or in combination with anti-PD-1/L1 therapy in patients with locally advanced or metastatic solid tumors. The study is divided into two parts: Phase 1 (Part A) focuses on determining the pharmaceutically active dosage range and evaluating the safety profile of PTT-936 when administered as a monotherapy. Phase 2a (Part B) will assess the safety and efficacy of PTT-936 combined with anti-PD-1/L1 therapy in patients suitable for anti- PD-1/L1 monotherapy. The study aims to understand how PTT-936, alone or in combination, impacts tumor progression and patients' overall response.
- Being tested
- PTT-936, Combination of PTT-936 and anti-PD-1/L1 therapy
- Keywords
- Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTT-936Drug
Eligible patients will receive single-agent PTT-936 administered per orally (PO).
Combination of PTT-936 and anti-PD-1/L1 therapyDrug
Eligible patients will receive combination treatment consisting of PTT-936 administered PO in combination with a Standard of Care (SOC) regimen of an anti-PD-1/L1 agent administered intravenously (IV).
| Study group | Role | What they receive |
|---|---|---|
| PTT-936 Dose Level 1 | Experimental | PTT-936 will be administered once a week (QW) Receives: Drug: PTT-936 |
| PTT-936 Dose Level 2 | Experimental | PTT-936 will be administered once a week (QW) Receives: Drug: PTT-936 |
| PTT-936 Dose Level 3 | Experimental | PTT-936 will be administered once a week (QW) Receives: Drug: PTT-936 |
| PTT-936 Dose Level 4 | Experimental | PTT-936 will be administered once a week (QW) Receives: Drug: PTT-936 |
| PTT-936 Dose Level 5 | Experimental | PTT-936 will be administered once a week (QW) Receives: Drug: PTT-936 |
| PTT-936 and anti-PD-1/L1 combination therapy | Experimental | PTT-936 will be administered once a week (QW) in combination with a standard-of-care (SOC) regimen of an anti-PD-1/L1 agent every three weeks (Q3W) Receives: Drug: Combination of PTT-936 and anti-PD-1/L1 therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of TEAEs and TRAEs (with severity determined using NCI CTCAE v5.0), Grade >3 TEAEs, Grade >3 TRAEs, SAEs, and AESIs
Measured: 7 months
Overall Response Rate (ORR): defined as the percentage of patients who achieved Complete Response (CR) or Partial Response (PR) according to RECIST v1.1 and iRECIST during the study
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start26 Jan 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Solid TumorsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pyrotech Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244992
- Sponsor's protocol ID
- PTT-936-101
- Status last verified
- Aug 2026
- First submitted
- 16 Jan 2024
- Last updated
- 10 Aug 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 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PTT-936, an Alpha Kinase 1 (ALPK1) Activator, Alone or in Combination With Anti-PD-1/L1 in Patients With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06244992
- Acronym / sponsor ID
- PTT-936-101
- Keywords
- Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Pyrotech Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 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 Phase 1/2a study will explore the safety and efficacy of PTT-936, an Alpha Kinase 1 (ALPK1) activator, used alone or in combination with anti-PD-1/L1 therapy in patients with locally advanced or metastatic solid tumors. The study is divided into two parts: Phase 1 (Part A) focuses on determining the pharmaceutically active dosage range and evaluating the safety profile of PTT-936 when administered as a monotherapy. Phase 2a (Part B) will assess the safety and efficacy of PTT-936 combined with anti-PD-1/L1 therapy in patients suitable for anti- PD-1/L1 monotherapy. The study aims to understand how PTT-936, alone or in combination, impacts tumor progression and patients' overall response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| PTT-936 Dose Level 1 | Experimental | Drug: PTT-936PTT-936 will be administered once a week (QW) |
| PTT-936 Dose Level 2 | Experimental | Drug: PTT-936PTT-936 will be administered once a week (QW) |
| PTT-936 Dose Level 3 | Experimental | Drug: PTT-936PTT-936 will be administered once a week (QW) |
| PTT-936 Dose Level 4 | Experimental | Drug: PTT-936PTT-936 will be administered once a week (QW) |
| PTT-936 Dose Level 5 | Experimental | Drug: PTT-936PTT-936 will be administered once a week (QW) |
| PTT-936 and anti-PD-1/L1 combination therapy | Experimental | Drug: Combination of PTT-936 and anti-PD-1/L1 therapyPTT-936 will be administered once a week (QW) in combination with a standard-of-care (SOC) regimen of an anti-PD-1/L1 agent every three weeks (Q3W) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Voluntarily signed informed consent form (ICF).
- Ability and willingness to adhere to all study procedures.
- Male or female patients ≥ 18 years of age at the time of signing the ICF.
- Locally advanced unresectable or metastatic solid tumor confirmed by histology or cytology
- For Part A: On tumor imaging, as assessed by RECIST v1.1 and iRECIST, with measurable or unmeasurable disease. For Part B: On tumor imaging, as assessed by RECIST v1.1 and iRECIST, with at least one measurable disease.
Key exclusion criteria (19 listed)
- Patients with leptomeningeal (LMD) metastases or patients with new and/or progressive brain metastases at the time of study entry. Patients with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after central nervous system (CNS)-directed treatment (radiotherapy and/or surgery), as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period.
- History of primary malignancy other than the diseases under study, not in remission greater than three (3) years prior to Day 1. Exceptions that do not require a 3-year remission include: adequately treated non-melanoma skin cancer, cervical carcinoma in situ on biopsy or squamous intraepithelial lesion on Papanicolaou (PAP) smear, in situ prostate cancer (with no evidence of active disease for two [2] years prior to Day 1), or resected melanoma in situ and radically resected papillary thyroid carcinoma.
- Persistence of Adverse Events (AEs) from prior anti-cancer therapy that have not resolved to Grade 1 (except for alopecia and hypothyroidism), or any history of Grade ≥ 3 immune-related adverse events (irAEs), Grade ≥ 2 pneumonitis, hypophysitis or encephalitis related to immunotherapy, or other Grade ≥ 3 drug-related CNS toxicity.
- Active systemic autoimmune disease or a history of autoimmune disorder that may relapse (e.g., systemic lupus erythematosus [SLE], rheumatoid arthritis, inflammatory bowel disease [IBD], autoimmune thyroid disorder*, multiple sclerosis, vasculitis, glomerulitis, eczema, psoriasis, etc.).
- Note that primary or secondary hypothyroidism, well controlled with hormone replacement therapy is permitted.
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 |
|---|---|---|
| PTT-936Eligible patients will receive single-agent PTT-936 administered per orally (PO). | Drug | PTT-936 Dose Level 1, PTT-936 Dose Level 2, PTT-936 Dose Level 3, PTT-936 Dose Level 4, PTT-936 Dose Level 5 |
| Combination of PTT-936 and anti-PD-1/L1 therapyEligible patients will receive combination treatment consisting of PTT-936 administered PO in combination with a Standard of Care (SOC) regimen of an anti-PD-1/L1 agent administered intravenously (IV). | Drug | PTT-936 and anti-PD-1/L1 combination therapy |
Primary outcome
Incidence of TEAEs and TRAEs (with severity determined using NCI CTCAE v5.0), Grade >3 TEAEs, Grade >3 TRAEs, SAEs, and AESIs
Time frame: 7 months
Overall Response Rate (ORR): defined as the percentage of patients who achieved Complete Response (CR) or Partial Response (PR) according to RECIST v1.1 and iRECIST during the study
Time frame: 7 months
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 10 Aug 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.
Precision NextGen Oncology and Research Center
Beverly Hills, United States
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PTT-936 and Combination of PTT-936 and anti-PD-1/L1 therapy in people with Locally Advanced or Metastatic Solid Tumors, run by Pyrotech Therapeutics, Inc. at 6 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 16 inclusion and 19 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 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, China. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of TEAEs and TRAEs (with severity determined using NCI CTCAE v5.0), Grade >3 TEAEs, Grade >3 TRAEs, SAEs, and AESIs (time frame: 7 months). The study lists 2 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 10 Aug 2026.