A Study of TPD3310 in Patients With Advanced Malignant Tumors

NCT07368127 | Not Yet Recruiting Phase 1

• 1 other identifier: TBD CA101
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multicenter, open phase I clinical study of dose escalation,cohort expansion study to evaluate the safety,tolerability,pharmacokinetics,pharmacodynamics, and preliminary efficacy of TPD3310 in patients withadvanced malignant solid tumors.

Conditions

Advanced Malignant Solid Tumors

Keywords

Neoplasms; Antineoplastic Agents

Outcome Measures

Primary Outcomes (4)

• Phase Ia: Dose-Limiting Toxicity (DLT)

  Continuously monitor safety; record toxic events meeting predefined criteria (NCI-CTCAE V5.0 Grade 3/4 non-hematological toxicity, Grade 4 hematological toxicity \>7 days, etc.). Include subjects with ≥75% planned dose or withdrawal due to DLT; causality confirmed by investigators.

  From enrollment to the end of cycle 1,cycle 1 has 28 days.

• Phase Ia: Maximum Tolerated Dose (MTD)

  Adopt accelerated titration + "3+3" design; calculate DLT incidence per dose group. MTD is the maximum dose with ≤1/6 DLT cases, requiring at least 6 evaluable subjects.

  Through the completion of cycle 1 for all phase Ia subjects,an average of 1 year.

• Phase Ia: Assessment of safety and toxicity profile

  Number of participants who experienced AEs, SAEs, and changes in physical examination, vital signs, ECOG score,imaging examination, laboratory tests, and 12-lead electrocardiogram, etc.

  From enrollment until the 28 days after the last study dose.

• Phase Ib: Objective Response Rate (ORR)

  Evaluate by contrast-enhanced CT/MRI (RECIST v1.1; mRECIST for hepatocellular carcinoma). ORR = proportion of subjects with CR+PR (first response confirmed after 4 weeks).

  From enrollment to the date of first documented progression or death due to any cause, whichever came first (up to approximately 2 years).

Secondary Outcomes (12)

• Phase Ia: Objective Response Rate (ORR)

  From enrollment to the date of first documented progression or death due to any cause, whichever came first (up to approximately 2 years).

• Phase Ia and Phase Ib: Disease Control Rate (DCR)

  From enrollment to the date of first documented progression or death due to any cause, whichever came first (up to approximately 2 years).

• Phase Ia and Phase Ib: Duration of Response (DOR)

  From enrollment to the date of first documented progression or death due to any cause, whichever came first (up to approximately 2 years).

• Phase Ia and Phase Ib: Progression-Free Survival (PFS)

  From enrollment to the date of first documented progression or death due to any cause, whichever came first (up to approximately 2 years).

• Phase Ia and Phase Ib: Overall Survival (OS)

  From enrollment to the date of death due to any cause (up to approximately 2 years).

Study Arms (1)

TPD3310 monotherapy

EXPERIMENTAL

• Phase Ia: Single and Multiple Dose Escalation. • Phase Ib: Cohort Expansion.

Drug: TPD3310 injection

Interventions

TPD3310 injection DRUG

* Phase Ia: Single and Multiple Dose Escalation. (1) Dosage form: injection. (2) Dosage: 6 dose groups, 50 mg, 100 mg, 200 mg, 350 mg, 500 mg, 650 mg,.-Arms Assigned Interventions (3) Frequency: once weekly. (4) Duration: days 1-21; 28 days per cycle. * Phase Ib: Cohort Expansion. Dosage and dosing regimen: according to the recommended dosage and dosing cycle from the Phase Ia study.

TPD3310 monotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign the informed consent form and follow protocol requirements.
• Aged 18 to 75 (both inclusive), male or female, regardless of race.
• Expected survival period ≥ 12 weeks.
• ECOG PS score ≤1.
• Phase Ia study:
• Patients with pathologically or cytologically confirmed advanced malignant solid tumors (not limited to lung cancer, gastric cancer, liver cancer and cholangiocarcinoma, esophageal cancer, pancreatic cancer, and renal cancer) who have progressive disease despite standard treatment, are intolerant to standard treatment, or lack effective standard treatment; c-MET positive patients are preferred. At least one measurable lesion meeting RECIST v1.1 criteria;
• Phase Ib study:
• Cohort A (histologically or cytologically confirmed lung cancer, failed or intolerant to standard treatment, EGFR wild-type, c-MET positive. Investigators may adjust enrollment criteria after communicating with the sponsor based on subjects' efficacy responses during the trial.), Cohort B (histologically or cytologically confirmed esophageal cancer, failed or intolerant to standard treatment, c-MET positive. Investigators may adjust enrollment criteria after communicating with the sponsor based on subjects' efficacy responses during the trial.), Cohort C (histologically or cytologically confirmed gastric cancer (including gastroesophageal junction adenocarcinoma), failed or intolerant to standard treatment, c-MET positive. Investigators may adjust enrollment criteria after communicating with the sponsor based on subjects' efficacy responses during the trial.), Cohort D (histologically or cytologically confirmed liver cancer and cholangiocarcinoma, failed or intolerant to standard treatment, c-MET positive. Investigators may adjust enrollment criteria after communicating with the sponsor based on subjects' efficacy responses during the trial.), Cohort E(histologically or cytologically confirmed pancreatic cancer, failed or intolerant to standard treatment, c-MET positive.Investigators may adjust enrollment criteria after communicating with the sponsor based on subjects' efficacy responses during the trial.), Cohort F(histologically or cytologically confirmed renal cancer, failed or intolerant to standard treatment, c-MET positive. Investigators may adjust enrollment criteria after communicating with the sponsor based on subjects' efficacy responses during the trial.) or other sensitive tumor types identified in phase Ia trial.
• Each cohort of participants had at least one measurable lesion that met the criteria of RECIST v1.1.
• Recovered from toxic effects of previous last treatment before the first dose (CTCAE ≤ Grade 1, except for special cases such as alopecia and hyperpigmentation); in addition, investigators judge that the corresponding AE has no safety risks.
• Systolic blood pressure ≤ 160 mmHg, diastolic blood pressure ≤ 100 mmHg, and no changes in antihypertensive drugs and dosages within 7 days before the first dose.
• Organ and bone marrow function must meet the following requirements:
• Bone marrow: Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L, platelet count ≥ 75×10⁹/L, hemoglobin ≥ 90 g/L; no blood transfusion or biologic response modifier (e.g., granulocyte colony-stimulating factor, erythropoietin, interleukin-11, etc.) treatment within 14 days before the first dose.
• Liver function: No history of cirrhosis (i.e., no decompensated cirrhosis Child-Pugh Class B or C). For subjects without liver metastasis: serum total bilirubin (TBIL) ≤ 1.5×upper limit of normal (ULN) (≤ 2.0×ULN for Gilbert syndrome), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN. For subjects with liver metastasis or liver cancer: TBIL ≤ 2.5×ULN, ALT and AST ≤ 5×ULN.
• Renal function: Creatinine clearance rate ≥ 50 mL/min (Cockcroft-Gault formula) or serum creatinine \< 1.5×ULN; urine protein qualitative ≤ 1+. If urine protein qualitative ≥ 2+, 24-hour urine protein quantitative test is required; investigators make enrollment judgment based on test results.

You may not qualify if:

• Previous or current history of other types of malignant tumors, except for the following situations:
• Curatively treated basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the breast.
• Second primary cancer that has been cured with no recurrence within 5 years.
• Subjects allergic to any component of the study drug or with a history of severe allergies.
• Received any of the following treatments or drugs before the first study treatment:
• Major surgery or severe trauma within 4 weeks before the first study drug administration (major surgery is defined as any invasive surgery involving extensive resection or opening of mesothelial barriers such as pleural cavity, peritoneal cavity, or meninges; however, tissue biopsy for diagnostic purposes is allowed. Severe trauma refers to unhealed wounds, ulcers, or fractures).
• Traditional Chinese medicine (including proprietary Chinese medicine) with antitumor indications within 2 weeks before the first study drug administration.
• Antitumor treatment (including chemotherapy, radiotherapy, immunotherapy, targeted therapy, biotherapy, or tumor embolization) within 2 weeks before the first dose or within 2 half-lives of the therapeutic drug (whichever is shorter).
• Strong CYP3A4 inducers or inhibitors within 2 weeks before the first dose and for less than 5 half-lives.
• Drugs known to significantly prolong the QT interval (e.g., Class Ia and III antiarrhythmic drugs) within 1 week before the first dose.
• Subjects with meningeal metastasis.
• Subjects with a history of other central nervous system (CNS) metastases or spinal cord compression; enrollment is allowed if the following conditions are met:
• Clearly received treatment and clinically stable after discontinuing anticonvulsants and steroids for 4 weeks before the first study drug administration (clinical stability is defined as no clinical accompanying symptoms such as increased intracranial pressure or neurological symptoms within 4 weeks and imaging suggesting stable lesions within 4 weeks before the first dose).
• For subjects with brain metastasis: Interval from whole-brain radiotherapy (WBRT) to the first study treatment administration ≥ 21 days; interval from stereotactic radiosurgery (SRS) to the first study treatment administration ≥ 7 days; or interval from surgical resection to the first study treatment administration ≥ 28 days.
• Advanced subjects with symptomatic visceral dissemination at risk of life-threatening complications in the short term; subjects who underwent at least two puncture drainages within 4 weeks before the first dose; or subjects who underwent one puncture drainage but with unstable pleural effusion, peritoneal effusion, or pericardial effusion.

Sponsors & Collaborators

• TAIBIDI PHARMACEUTICAL TECHNOLOGY(SHIJIAZHUANG) CO.,LTD.: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Ning Li, M.D.

CONTACT

8610-87788713; lining@cicams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2026
• First Posted: January 26, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: January 26, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)