Actively Recruiting
TAVO412 Study Evaluating Safety and Dosage in Patients with Advanced or Metastatic Solid Tumors An Open-Label, Non-Randomized Phase I Trial with Intravenous TAVO412 Treatment
Led by Tavotek Biotherapeutics · Updated on 2025-01-16
50
Participants Needed
6
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating TAVO412 in a Phase I, open-label, non-randomized study to assess its safety, tolerability, pharmacokinetics, pharmacodynamics, and early signs of effectiveness in adults with advanced or metastatic solid tumors who have progressed after standard treatments. The study has two parts: Part 1 uses a dose-escalation design to find the maximum tolerated dose and recommended phase 2 dose (MTD/RP2D), while Part 2 expands to further evaluate these doses in patients with specific cancers or those with the best clinical responses from Part 1 who have progressed. Participants receive TAVO412 intravenously on days 1 and 15 of the first treatment cycle and continue this bi-weekly schedule for subsequent cycles. Part 1 focuses on dose escalation and identifying optimal dosing, whereas Part 2 tests the selected dose in new patients with advanced gastric cancer, non-small cell lung cancer, or other solid tumors as defined. Tumor biopsies and blood samples for biomarker and genetic testing are collected at baseline and, when appropriate, at the end of treatment. Throughout the study, participants undergo regular assessments including safety monitoring for adverse events and dose-limiting toxicities over approximately 12 months. Researchers collect laboratory tests, imaging, tumor response evaluations, and pharmacokinetic data. Safety and efficacy data are closely observed to determine the tolerability and preliminary anti-cancer effects of TAVO412 in this patient population.
CONDITIONS
Official Title
A Study of TAVO412 in Patients with Cancer (TAVO412)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older at screening
- Signed informed consent and able to complete all trial procedures
- Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors that failed standard therapy or have no standard therapy
- ECOG performance status of 0 or 1
- Expected survival of at least 3 months
- Phase 2 participants must have at least one measurable lesion per RECIST v1.1; Phase 1 participants may have measurable or non-measurable lesions
- Subjects in Phase 1 with advanced or metastatic solid tumors who failed or have no standard treatment
- Phase 2 subjects with advanced or metastatic gastric cancer, non-small cell lung cancer, liver cancer, or other solid tumors with best clinical responses from Phase 1
- Agreement to tumor biopsy and blood sample collection for biomarker and genetic testing as appropriate
- Female subjects of childbearing potential must have a negative pregnancy test and agree to use effective contraception
- Male subjects must agree to use effective contraception
- Laboratory tests within specified normal ranges prior to treatment start
- HIV, hepatitis B, or hepatitis C infected subjects may participate under specific viral load and treatment conditions
You will not qualify if you...
- Received anticancer or investigational drugs within specified washout periods before first dose (chemotherapy, targeted therapy, radiotherapy within 14 days; immunotherapy or cell therapy within 28 days; monoclonal antibodies within 28 days except denosumab; Chinese medicine within 14 days; immunosuppressive therapy within 7 days)
- Not recovered from toxic effects of prior therapy above Grade 1 (except stable chronic adverse events)
- History of severe or uncontrollable ocular disease
- History of prior Grade 3 or higher therapy-related adverse events (excluding hematologic) in dose escalation
- Other active malignant tumors except some cured >5 years ago
- Significant cardiac disease within 6 months prior to study drug administration
- Poorly controlled effusions in body cavities
- Recent gastrointestinal bleeding within past 3 months without confirmed recovery
- Evidence of gastric bleeding or perforation
- Pyloric obstruction, persistent vomiting, or acute intestinal obstruction
- History of ulcerative colitis or Crohn's disease
- Active colitis within 4 weeks prior to screening
- Received live vaccines within 30 days before study drug start
- Active autoimmune disease requiring systemic therapy
- Known active central nervous system metastases or carcinomatous meningitis
- Active non-infectious pneumonitis during screening
- Serious vascular embolic events requiring intervention
- Active infection requiring systemic treatment
- Known allergy to any study drug component
- Pregnant or lactating females or males planning to impregnate during study period
- Any condition interfering with study participation or safety as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Affiliated Cancer Hospital of Chongqing University
Chongqing, Chongqing Municipality, China
Not Yet Recruiting
2
First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Not Yet Recruiting
3
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Actively Recruiting
4
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
5
Hubei Cancer Hospital
Wuhan, Hubei, China
Actively Recruiting
6
Jinan Central Hospital
Jinan, Shandong, China
Actively Recruiting
Research Team
Y
Yanjiao Yu, Bachelor
W
Wei Zhang, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
7
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