Actively Recruiting
A Study of TAVO412 in Patients with Cancer (TAVO412)
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
TAVO412 Phase 1 is an open-label, non-randomized, 2-part Phase I study to examine the safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy of TAVO412. Part 1 will utilize a standard 3 + 3 design to determine the MTD/RP2D of TAVO412 in subjects with advanced or metastatic solid tumors who progressed on prior approved standard of care therapy. Part 2 will further evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), and pharmacologic activity of TAVO412 in a new set of subjects with advanced or metastatic gastric cancer, non-small cell lung cancer (NSCLC), or subjects of other solid tumor types with best clinical responses (e.g., CR \> PR \> SD) from Part 1 that progressed on prior approved standard of care therapy.
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
Complete this quick 3-step screening to check your eligibility
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
CONTACT
W
Wei Zhang, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
7
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here