Solid TumorPhase 1/2NCT06971523
A Phase I/II Clinical Study of CTS3497 in Patients With MTAP Deficient Malignacies
A Phase 1/2 study testing CTS3497 in people with Solid Tumor and Lymphoma, run by CytosinLab Therapeutics Co., Ltd. at 1 site in China.
Trial summary
The primary objective of Phase I of this study is to evaluate the safety and tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of CTS3497 in patients with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deficient solid tumors and lymphomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Lymphoma
- What is being tested?
- CTS3497
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2024to 30 Jun 2029
- 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
- ≥ 18 years of age at the signing of ICF.
- Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumors who cannot be treated surgically and have failed standard of care (SoC). Or patients with refractory/relapsed lymphomas.
- MTAP deficiency is confirmed by IHC or NGS.
- At least one evaluable tumor lesion at screening for patients in escalation part, and at least one measurable tumor lesion for patients in expansion part.
- ECOG performance status of 0 to 1.
- Adequate hematopoietic function, cardiac function, liver function, renal function, and coagulation function per local laboratory.
Who cannot join
- Female patients in pregnancy or lactation.
- Patients with dysphagia; or a condition that seriously affects gastrointestinal absorption.
- Allergic or intolerant to the active ingredients or excipients of the investigational product.
- Anti-tumor therapy within 28 days of study day 1.
- Prior treatment with an methionine adenosyltransferase 2α (MAT2A) inhibitor or a protein arginine methyltransferase 5 (PRMT5) inhibitor.
- Central nervous system (CNS) metastasis at screening.
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- Live vaccine therapy within 4 weeks before study drug administration.
- Use of therapeutic anti-coagulation for treatment of active thromboembolic events.
- Use of prescription medications that are known strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) within 14 days or 5 half-lives (whichever is longer) before study day 1.
- Unresolved toxicity from prior anti-cancer therapy.
- Active infection of HIV, HBV or HCV.
- Patients who are judged by the investigator to have a history of other serious systemic diseases, or not suitable for participating in the trial for any other reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Lin Shen, MD, 0086-10-88196561, linshenpku@163.com
Jifang Gong, MD, 0086-10-88196561, goodjf@163.com
About this study
Official title: A Multi-center, Open-label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of CTS3497 in Patients With MTAP Deficient Advanced Solid Tumors and Lymphomas
The primary objective of Phase I of this study is to evaluate the safety and tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of CTS3497 in patients with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deficient solid tumors and lymphomas.
The primary objective of Phase II of this study is to evaluate the efficacy of CTS3497 in patients with metastatic or locally advanced MTAP-deficient solid tumors and lymphomas.
Read the detailed description
The primary objective of Phase I of this study is to evaluate the safety, tolerability, PK, PD and efficacy to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of CTS3497 in patients with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deficient solid tumors and lymphomas.
The primary objective of Phase II of this study is to evaluate the efficacy and safety of CTS3497 in patients with metastatic or locally advanced MTAP-deficient solid tumors and lymphomas.
- Conditions
- Solid Tumor, Lymphoma
- Being tested
- CTS3497
- Keywords
- PRMT5
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTS3497Drug
Also called CTS3497 capsules
CTS3497: Orally via capsules
| Study group | Role | What they receive |
|---|---|---|
| Phase I: CTS3497 Monotherapy Dose Escalation/Dose Expansion | Experimental | 7 dose groups are pre-specified in Dose Escalation,and 2-3 dose groups in Dose Expansion. Receives: Drug: CTS3497 |
| Phase II: CTS3497 Monotherapy Expansion | Experimental | CTS3497 RP2D administered to patients with MTAP homozygous deletion including the following cohorts: esophageal squamous cell carcinoma [ESCC], pancreatic adenocarcinoma [PAAD], biliary tract cancer [BTC], non-small cell lung carcinoma[NSCLC], malignant pleural mesothelioma [MPM], Urothelial cancer, high-grade gliomas, other solid tumors, and lymphomas. Receives: Drug: CTS3497 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Number of Patients Who Experience a Dose-Limiting Toxicity (DLT)
Incidence of DLT(s) during the DLT observation period
Measured: Up to 21 days after the first administration.
Phase I: Number of Patients Who Experience a Treatment-emergent Adverse Event (TEAE)
Adverse events (AEs) are defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECGs) and clinical laboratory tests will be recorded as TEAEs.
Serious AEs (SAEs) are defined as any event that meets at least 1 of the following criteria:
resulting in death (fatal); requiring in-patient hospitalization or prolongation of existing hospitalization; resulting in persistent or significant disability/incapacity; being a congenital anomaly/birth defect; other medically important serious event.
Measured: Baseline through 28 days after the end of treatment, estimated up to 52 weeks.
Phase II: Objective Response Rate (ORR)
The percentage of participants having complete response (CR) or partial response (PR) assessed based on RECIST V1.1.
Measured: up to 48 weeks.
Secondary outcomes (9)
Cmax of CTS3497
Maximal Plasma Concentration
Measured: Cycle 1 (each cycle is 21 days) Day 1, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 5 Day 1
Tmax of CTS3497
Time to Achieve Maximal Plasma Concentration
Measured: Cycle 1 (each cycle is 21 days) Day 1, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 5 Day 1
AUC of CTS3497
Area Under the Plasma Concentration Versus Time Curve
Measured: Cycle 1 (each cycle is 21 days) Day 1, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 5 Day 1
Disease control rate (DCR)
Disease Control Rate assessed by investigators based on RECIST v1.1
Measured: up to 48 weeks.
Duration of Response (DoR)
Duration of response (DOR) assessed based on the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1.
Measured: Estimated up to 48 weeks.
Progression-Free Survival (PFS)
Progression-Free Survival assessed by investigators based RECIST v1.1
Measured: Estimated up to 48 weeks.
Overall Survival (OS)
Overall Survival after first dose
Measured: Up to approximately 3 years.
Pharmacodynamic (PD) characteristics of CTS3497: symmetric dimethylarginine (SDMA)
To explore the changes of symmetric dimethylarginine (SDMA) in blood of patients with solid tumors and lymphomas before and after administration of CTS3497.
Measured: Cycle 1 (each cycle is 21 days) Day 1, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 5 Day 1 and Cycle 7 Day 1
Pharmacodynamic (PD) characteristics and efficacy analysis.
The correlation between the changes of symmetric dimethylarginine (SDMA) in blood of patients and the efficacy of CTS3497
Measured: Estimated up to 48 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start25 Dec 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CytosinLab Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Haiping Wu, PhD, Study chair, CytosinLab Therapeutics Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971523
- Sponsor's protocol ID
- CTS3497-CI01
- Status last verified
- Apr 2025
- First submitted
- 28 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of CTS3497 in Patients With MTAP Deficient Advanced Solid Tumors and Lymphomas
- ClinicalTrials.gov ID
- NCT06971523
- Acronym / sponsor ID
- CTS3497-CI01
- Conditions
- Solid Tumor, Lymphoma
- Keywords
- PRMT5
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- CytosinLab Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Dec 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 14 May 2025 (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.
The primary objective of Phase I of this study is to evaluate the safety and tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of CTS3497 in patients with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deficient solid tumors and lymphomas.
The primary objective of Phase II of this study is to evaluate the efficacy of CTS3497 in patients with metastatic or locally advanced MTAP-deficient solid tumors and lymphomas.
Detailed description
The primary objective of Phase I of this study is to evaluate the safety, tolerability, PK, PD and efficacy to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of CTS3497 in patients with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deficient solid tumors and lymphomas.
The primary objective of Phase II of this study is to evaluate the efficacy and safety of CTS3497 in patients with metastatic or locally advanced MTAP-deficient solid tumors and lymphomas.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I: CTS3497 Monotherapy Dose Escalation/Dose Expansion | Experimental | Drug: CTS34977 dose groups are pre-specified in Dose Escalation,and 2-3 dose groups in Dose Expansion. |
| Phase II: CTS3497 Monotherapy Expansion | Experimental | Drug: CTS3497CTS3497 RP2D administered to patients with MTAP homozygous deletion including the following cohorts: esophageal squamous cell carcinoma [ESCC], pancreatic adenocarcinoma [PAAD], biliary tract cancer [BTC], non-small cell lung carcinoma[NSCLC], malignant pleural mesothelioma [MPM], Urothelial cancer, high-grade gliomas, other solid tumors, and lymphomas. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 18 years of age at the signing of ICF.
- Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumors who cannot be treated surgically and have failed standard of care (SoC). Or patients with refractory/relapsed lymphomas.
- MTAP deficiency is confirmed by IHC or NGS.
- At least one evaluable tumor lesion at screening for patients in escalation part, and at least one measurable tumor lesion for patients in expansion part.
- ECOG performance status of 0 to 1.
Key exclusion criteria (12 listed)
- Female patients in pregnancy or lactation.
- Patients with dysphagia; or a condition that seriously affects gastrointestinal absorption.
- Allergic or intolerant to the active ingredients or excipients of the investigational product.
- Anti-tumor therapy within 28 days of study day 1.
- Prior treatment with an methionine adenosyltransferase 2α (MAT2A) inhibitor or a protein arginine methyltransferase 5 (PRMT5) inhibitor.
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 |
|---|---|---|
| CTS3497Also: CTS3497 capsulesCTS3497: Orally via capsules | Drug | Phase I: CTS3497 Monotherapy Dose Escalation/Dose Expansion, Phase II: CTS3497 Monotherapy Expansion |
Primary outcome
Phase I: Number of Patients Who Experience a Dose-Limiting Toxicity (DLT)
Time frame: Up to 21 days after the first administration.
Incidence of DLT(s) during the DLT observation period
Phase I: Number of Patients Who Experience a Treatment-emergent Adverse Event (TEAE)
Time frame: Baseline through 28 days after the end of treatment, estimated up to 52 weeks.
Adverse events (AEs) are defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECGs) and clinical laboratory tests will be recorded as TEAEs. Serious AEs (SAEs) are defined as any event that meets at least 1 of the following criteria: resulting in death (fatal); requiring in-patient hospitalization or prolongation of existing hospitalization; resulting in persistent or significant disability/incapacity; being a congenital anomaly/birth defect; other medically important serious event.
Phase II: Objective Response Rate (ORR)
Time frame: up to 48 weeks.
The percentage of participants having complete response (CR) or partial response (PR) assessed based on RECIST V1.1.
9 secondary outcomes
Cmax of CTS3497
Time frame: Cycle 1 (each cycle is 21 days) Day 1, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 5 Day 1
Tmax of CTS3497
Time frame: Cycle 1 (each cycle is 21 days) Day 1, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 5 Day 1
AUC of CTS3497
Time frame: Cycle 1 (each cycle is 21 days) Day 1, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 5 Day 1
Disease control rate (DCR)
Time frame: up to 48 weeks.
Duration of Response (DoR)
Time frame: Estimated up to 48 weeks.
Progression-Free Survival (PFS)
Time frame: Estimated up to 48 weeks.
Overall Survival (OS)
Time frame: Up to approximately 3 years.
Pharmacodynamic (PD) characteristics of CTS3497: symmetric dimethylarginine (SDMA)
Time frame: Cycle 1 (each cycle is 21 days) Day 1, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 5 Day 1 and Cycle 7 Day 1
Pharmacodynamic (PD) characteristics and efficacy analysis.
Time frame: Estimated up to 48 weeks.
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 14 May 2025.
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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.
Haiping Wu, PhD study chair
CytosinLab Therapeutics Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CTS3497 in people with Solid Tumor and Lymphoma, run by CytosinLab Therapeutics Co., Ltd. at 1 site in China.
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 6 inclusion and 12 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 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Contact Shuning Xing, MS (0086-21-58920766, shuning.xing@cytosinlab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Number of Patients Who Experience a Dose-Limiting Toxicity (DLT) (time frame: Up to 21 days after the first administration.). The study lists 3 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 14 May 2025.