Advanced Solid TumorsPhase 1NCT06998173
Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of DAT-1604 in Advanced Solid Tumor
A Phase 1 study testing DAT-1604 tablet in people with Advanced Solid Tumors, run by Danatlas Pharmaceuticals Co., Ltd at 1 site in China.
Trial summary
The primary objective of the study is to evaluate the safety, tolerability, PK, and preliminary efficacy of a Polθ Inhibitor DAT-1604 in patients with advanced/metastatic solid tumors, which is refractory to standard therapies, or for which no standard therapies exist. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- DAT-1604 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2025to 30 Jul 2028
- 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
- Signed informed consent.
- Male or female aged ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
- Advanced or metastatic solid tumor, which is refractory to standard therapies, or for which no standard therapies exist.
- Non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available for submission for analysis.
- Discontinued all previous treatments for cancer for at least 21 days or 5 half-lives, whichever is shorter, and recovered from the acute effects of therapy. Palliative radiotherapy must have completed 1 week prior to start of study treatment.
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- At least 1 radiologically evaluable lesion (measurable and/or non-measurable) that can be assessed at baseline and is suitable for repeated radiological evaluation by RECIST v1.1 for subjects.
- Acceptable hematologic, renal, hepatic, and coagulation functions independent of transfusions and granulocyte colony-stimulating factor indicated by the following laboratory values:
- Hemoglobin (Hgb) greater than or equal to 10 g/dL;
- Leukocytes greater than or equal to 3,000/mcL;
- Absolute neutrophil count greater than or equal to 1,500/mcL;
- Platelets greater than or equal to 100,000/mcL;
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2 × upper limit of normal (ULN); if liver metastases, then ≤ 3 × ULN;
- Bilirubin ≤ 1.5 × ULN; < 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome;
- Serum albumin ≥ 30 g/L (3.0 g/dL);
- Creatinine clearance ≥ 60 mL/min (Cockcroft-Gault Equation).
- Willingness to abide by protocol defined contraceptive requirements for the duration of the study.
- Estimated life expectancy of ≥12 weeks.
- -
Who cannot join
- Subjects who are pregnant.
- Subjects with Myelodysplastic syndrome (MDS)/Acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
- Have ongoing interstitial lung disease or pneumonitis.
- Have any major gastrointestinal issues that could impact absorption of DAT-1604.
- Subjects with brain metastases (subjects with treated brain metastases could be eligible if follow-up brain imaging after central nervous system-directed therapy shows no evidence of progression at least more than 4 weeks without neuropsychiatric symptom).
- Have received a live vaccine within 30 days before the first dose of study treatment.
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- Recent major surgery within 4 weeks prior to entry into the study.
- Have a history of allergy or hypersensitivity to study drug components.
- Persistent toxicities ([CTCAE] Grade > 1) from prior anticancer therapy, excluding alopecia and CTCAE Grade 2 peripheral neuropathy.
- Any of the following ECG findings at Screening, Admission and/or pre dose on Day 1:
- Any out of range ECG parameter(s) or abnormal finding(s) considered clinically significant by the Investigator;
- Any ECG finding that, in the opinion of the Investigator, may compromise interpretation of ECG for cardiac safety assessments and/or complicate interpretation of events that may occur post dose (e.g., QT not accurately measurable, conduction abnormalities);
- QTcF > 470 ms;
- Any of the following: History or current evidence of congenital long QT syndrome; history of Torsades de Pointes, concomitant medications known to prolong QT interval or history of medication-related QT prolongation;
- Resting HR <50 bpm or >90 bpm when vital signs are measured at Screening or Admission.
- COVID-19 positive for active disease.
- Myocardial impairment of any cause (e.g., cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease or congestive heart failure) resulting in heart failure by New York Heart Association (NYHA) Criteria (Class III or IV staging).
- Current treatment with drugs known as sensitive substrates or substrates having a narrow therapeutic index of CYP2B6, CYP3A4, and transporters including OAT1 and OAT3.
- Have received inhibitors or inducers of P-gp within 2 weeks prior to receiving the first dose of study drug.
- Current treatment with drugs which can prolong QTc in adverse reaction.
- Current treatment with highly competitive protein binding medications, such as warfarin, phenytoin, chlorpromazine, doxorubicin, gentamicin, indomethacin, metoprolol, meclezine.
- Known hypersensitivity to study drug(s) or any of its constituents.
- Unwilling or unable to follow study restrictions and requirements
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
Cancer Hostital,Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Binghe Xu, MD, PhD, +86 13501028690, xubinghe@medmail.com.cn
About this study
Official title: Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DAT-1604 Tablets as Monotherapy in the Advanced Solid Tumor
The primary objective of the study is to evaluate the safety, tolerability, PK, and preliminary efficacy of a Polθ Inhibitor DAT-1604 in patients with advanced/metastatic solid tumors, which is refractory to standard therapies, or for which no standard therapies exist.
Read the detailed description
In Part 1, 6 dose cohorts will be set and defined maximum tolerated dose(MTD)/recommended dose for expansion (RDE). In Part 2, Food effects on pharmacokinetic of DAT-1604 will be assessed at RDE, and dose optimization will be conducted to definite recommended phase 2 dose (RP2D). Then , The RP2D expansion will be conducted in another 3 cohorts to evaluate the efficacy.
- Conditions
- Advanced Solid Tumors
- Being tested
- DAT-1604 tablet
- Keywords
- Polθ Inhibitor, Advanced Solid Tumors, Metastatic Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAT-1604 tabletDrug
DAT-1604, a potent and selective oral small molecule inhibitor of DNA Polymerase θ (Pol θ).
| Study group | Role | What they receive |
|---|---|---|
| Part 1, Dose escalation | Experimental | The part 1 is the dose escalation study, and set 6 dose level cohorts.On day 1 of cycle 1(C0D1), The patient takes DAT-1645 orally one time (single use) at the dose level in his or her enrollment cohort . Since C1D1(C0D4)，the DAT-1604 tablet is administered orally once daily at same dose level for 21 days per treatment cycle. Treatment continues until disease progression, or toxicity intolerance, or withdrawal from the study, or loss to follow-up, or initiation of new antitumor therapy, whichever occurs first. Receives: Drug: DAT-1604 tablet |
| Module 1 Part 2, dose expansion study to assess the food effects on pharmacokinetics（PK）. | Experimental | On day 1 of cycle 0 (C0D1), a single recommended oral dose of DAT-1604 is administered in the fasted state, withing a drug-free washout period of day 2 and day 3, and a single same dose of DAT-1604 is administered in the postprandial state on C0D4, with elution of the drug by C0D5, C0D6. Since C1D1(C0D7) , the DAT-1604 is administered orally once daily at the same dosage level, for 21 days as 1 treatment cycle , administered until disease progression, or toxicity intolerance, or withdrawal from the study, or loss to follow-up, or initiation of new antitumor therapy, or trial closure/termination, whichever occurs first. Receives: Drug: DAT-1604 tablet |
| Module 2 Part 2, optimized dose expansion | Experimental | The study sets two recommended dose levels. The patient will receive one of the dose levels, and be administered orally once daily at the same dosage level, for 21 days as 1 treatment cycle , administered until disease progression, or toxicity intolerance, or withdrawal from the study, or loss to follow-up, or initiation of new antitumor therapy, or trial closure/termination, whichever occurs first. Receives: Drug: DAT-1604 tablet |
| Module 3 Part 2, RP2D expansion | Experimental | The patient will be administered DAT-1604 with recommended phase 2 dose (RP2D) level, orally once daily , for 21 days as 1 treatment cycle , and administered until disease progression, or toxicity intolerance, or withdrawal from the study, or loss to follow-up, or initiation of new antitumor therapy, or trial closure/termination, whichever occurs first. Receives: Drug: DAT-1604 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
PART 1: Safety and Tolerability
To characterize the safety and tolerability of DAT-1604 monotherapy by evaluating the number of participants with dose limiting toxicities, adverse events, and laboratory abnormalities as graded by NCI CTCAE version 5.0
Measured: 12 months
PART 2: RP2D
Recommended Phase 2 dose(RP2D) will be definite by safety monitoring committee(SMC).
Measured: 12 months
Secondary outcomes (8)
ORR
Objective Response Rate (ORR) is defined as the proportion of patients that respond either partially or fully to therapy according to RECIST 1.1 criteria based on the CT-Scan.
Measured: 6 months
DCR
Disease control rate (DCR) is defined as the percentage of patients who have achieved CR, PR, Non-CR/Non- PD, or SD in the study.
Measured: 6 months
DOR
Duration of Response (DOR) is defined as the time from the earliest date of documented CR or PR until documented disease progression or death (by any cause, in the absence of progression) as determined by the Investigators using RECIST 1.1.
Measured: 1 year
PFS
Progression-free survival (PFS) is defined as the time from the date of first dose of study drug to the first observation of documented disease progression per RECIST 1.1 as determined by the Investigators or death due to any cause, whichever occurs first.
Measured: 2 years
OS
Overall survival (OS) is defined as the time from the date of first dose of study drug to the date of documented death due to any cause.
Measured: 2 years
AUC
To characterize the single dose PK area under the plasma concentration versus time curve (AUC) of DAT-1604 monotherapy.
Measured: 1 year
Tmax
To characterize the single dose PK time to peak drug concentration (Tmax) of DAT-1604 monotherapy.
Measured: 1 year
Cmax
To characterize the single dose PK peak plasma concentration (Cmax) of DAT-1604 monotherapy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start31 Jul 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danatlas Pharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998173
- Sponsor's protocol ID
- Danatlas Pharmaceuticals
- Status last verified
- May 2025
- First submitted
- 16 May 2025
- Last updated
- 31 May 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The efficacy and Safety data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DAT-1604 Tablets as Monotherapy in the Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT06998173
- Acronym / sponsor ID
- Danatlas Pharmaceuticals
- Conditions
- Advanced Solid Tumors
- Keywords
- Polθ Inhibitor, Advanced Solid Tumors, Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Danatlas Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 31 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 the study is to evaluate the safety, tolerability, PK, and preliminary efficacy of a Polθ Inhibitor DAT-1604 in patients with advanced/metastatic solid tumors, which is refractory to standard therapies, or for which no standard therapies exist.
Detailed description
In Part 1, 6 dose cohorts will be set and defined maximum tolerated dose(MTD)/recommended dose for expansion (RDE). In Part 2, Food effects on pharmacokinetic of DAT-1604 will be assessed at RDE, and dose optimization will be conducted to definite recommended phase 2 dose (RP2D). Then , The RP2D expansion will be conducted in another 3 cohorts to evaluate the efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1, Dose escalation | Experimental | Drug: DAT-1604 tabletThe part 1 is the dose escalation study, and set 6 dose level cohorts.On day 1 of cycle 1(C0D1), The patient takes DAT-1645 orally one time (single use) at the dose level in his or her enrollment cohort . Since C1D1(C0D4)，the DAT-1604 tablet is administered orally once daily at same dose level for 21 days per treatment cycle. Treatment continues until disease progression, or toxicity intolerance, or withdrawal from the study, or loss to follow-up, or initiation of new antitumor therapy, whichever occurs first. |
| Module 1 Part 2, dose expansion study to assess the food effects on pharmacokinetics（PK）. | Experimental | Drug: DAT-1604 tabletOn day 1 of cycle 0 (C0D1), a single recommended oral dose of DAT-1604 is administered in the fasted state, withing a drug-free washout period of day 2 and day 3, and a single same dose of DAT-1604 is administered in the postprandial state on C0D4, with elution of the drug by C0D5, C0D6. Since C1D1(C0D7) , the DAT-1604 is administered orally once daily at the same dosage level, for 21 days as 1 treatment cycle , administered until disease progression, or toxicity intolerance, or withdrawal from the study, or loss to follow-up, or initiation of new antitumor therapy, or trial closure/termination, whichever occurs first. |
| Module 2 Part 2, optimized dose expansion | Experimental | Drug: DAT-1604 tabletThe study sets two recommended dose levels. The patient will receive one of the dose levels, and be administered orally once daily at the same dosage level, for 21 days as 1 treatment cycle , administered until disease progression, or toxicity intolerance, or withdrawal from the study, or loss to follow-up, or initiation of new antitumor therapy, or trial closure/termination, whichever occurs first. |
| Module 3 Part 2, RP2D expansion | Experimental | Drug: DAT-1604 tabletThe patient will be administered DAT-1604 with recommended phase 2 dose (RP2D) level, orally once daily , for 21 days as 1 treatment cycle , and administered until disease progression, or toxicity intolerance, or withdrawal from the study, or loss to follow-up, or initiation of new antitumor therapy, or trial closure/termination, whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Signed informed consent.
- Male or female aged ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
- Advanced or metastatic solid tumor, which is refractory to standard therapies, or for which no standard therapies exist.
- Non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available for submission for analysis.
Key exclusion criteria (23 listed)
- Subjects who are pregnant.
- Subjects with Myelodysplastic syndrome (MDS)/Acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
- Have ongoing interstitial lung disease or pneumonitis.
- Have any major gastrointestinal issues that could impact absorption of DAT-1604.
- Subjects with brain metastases (subjects with treated brain metastases could be eligible if follow-up brain imaging after central nervous system-directed therapy shows no evidence of progression at least more than 4 weeks without neuropsychiatric symptom).
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 |
|---|---|---|
| DAT-1604 tabletDAT-1604, a potent and selective oral small molecule inhibitor of DNA Polymerase θ (Pol θ). | Drug | Module 1 Part 2, dose expansion study to assess the food effects on pharmacokinetics（PK）., Module 2 Part 2, optimized dose expansion, Module 3 Part 2, RP2D expansion, Part 1, Dose escalation |
Primary outcome
PART 1: Safety and Tolerability
Time frame: 12 months
To characterize the safety and tolerability of DAT-1604 monotherapy by evaluating the number of participants with dose limiting toxicities, adverse events, and laboratory abnormalities as graded by NCI CTCAE version 5.0
PART 2: RP2D
Time frame: 12 months
Recommended Phase 2 dose(RP2D) will be definite by safety monitoring committee(SMC).
8 secondary outcomes
ORR
Time frame: 6 months
DCR
Time frame: 6 months
DOR
Time frame: 1 year
PFS
Time frame: 2 years
OS
Time frame: 2 years
AUC
Time frame: 1 year
Tmax
Time frame: 1 year
Cmax
Time frame: 1 year
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 31 May 2025.
- Individual participant dataSharing planned: Yes. The efficacy and Safety data will be shared.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DAT-1604 tablet in people with Advanced Solid Tumors, run by Danatlas Pharmaceuticals 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 19 inclusion and 23 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: opening soon, as of the sponsor's last update on 31 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 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 Binghe Xu, MD, PhD (+86 13501028690, xubinghe@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PART 1: Safety and Tolerability (time frame: 12 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 31 May 2025.