A Phase 1 Study to Evaluate TGI-6 in Subjects With Locally Advanced/Metastatic Solid Tumors

NCT06374173 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: TGI6-T1-01
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 1 Study to Evaluate TGI-6 in Subjects with Locally Advanced/Metastatic Solid Tumors

Conditions

Advanced or Metastatic Solid Tumors

Keywords

TGI6; Colorectal Cancer; solid tumors

Outcome Measures

Primary Outcomes (3)

• Dose-limiting Toxicity (DLT)

  The incidence of DLTs during the DLT assessment period.

  First 21 days of treatment.

• Dose-Finding

  Determination of the MTD or maximum tested dose, and the RP2D.

  Approximately 3 years.

• Frequency and Severity of Adverse Events (AE)

  The incidences and percentages of patients experiencing AEs summarized by NCI CTCAE version 5.0 grade and by causality.

  Screening to 30 days from last dose

Secondary Outcomes (8)

• Pharmacokinetics of TGI-6

  Day 1 of dosing through 7 days post last dose

• Pharmacokinetics of TGI-6

  Day 1 of dosing through 7 days post last dose

• Number of subjects with Anti-TGI-6 antibody positive

  Day 1 of dosing through 7 days post last dose

• Objective Response Rate (ORR)

  Approximately 3 years.

• Duration of Response (DoR)

  Approximately 3 years

Study Arms (1)

TGI-6 Injection

EXPERIMENTAL

TGI-6 monotherapy dose escalation(Phase 1a) . TGI-6 monotherapy dose expansion(Phase 1b) .

Drug: TGI-6 Injection

Interventions

TGI-6 Injection DRUG

TGI-6 will be administered intravenously at a dose and schedule as specified for the respective study part and cohort.

TGI-6 Injection

Eligibility Criteria

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

You may qualify if:

• Male or female subjects age ≥18 years at the time of informed consent.
• Phase 1a: Subjects with histologically or cytologically diagnosed unresectable locally advanced/metastatic CRC. Or subjects with confirmed B7-H6-positive unresectable locally advanced/metastatic solid tumors, mainly but not limited to TNBC, HCC, HNSCC, SCLC, OC, GC, pancreatic cancer, and melanoma.
• Phase 1b Cohort 1: Subjects must have pathologically documented, definitively diagnosed unresectable locally advanced and/or metastatic CRC.
• Phase 1b Cohort 2: Subjects must have pathologically documented, definitively diagnosed unresectable locally advanced and/or metastatic solid tumors with B7-H6-positive, mainly but not limited to TNBC, HCC, HNSCC, SCLC, OC, GC, pancreatic cancer, and melanoma.
• Phase 1a or Phase1b Cohort 2: Subjects should have progressed despite all standard therapy or be intolerant of all standard therapy, or for whom no standard therapy exists. (Standard therapies are defined as treatments recommended by local guidelines, including, but not limited to, chemotherapy, radiation, target therapies based on mutation status, immunotherapy, and surgery in general).
• All subjects except subjects with CRC must agree to the collection of tumor samples for confirmation of B7-H6 expression status in a central lab.
• Subjects in Phase 1a must have at least one evaluable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Subjects in Phase 1b must have least one measurable lesion as defined per RECIST v1.1 which has not received radiotherapy (or progressive disease after radiotherapy).
• ECOG PS (Appendix 5) of 0\~2.
• Life expectancy ≥3 months.
• Subjects have sufficient baseline organ function and laboratory data .
• Woman of childbearing potential must have a negative serum pregnancy test within 7 days prior to treatment.
• Female subjects of childbearing potential or male subjects with a partner of childbearing potential must agree to use effective contraception at the time of informed consent and continuing through the study until 6 months after the last dose of TGI-6.

You may not qualify if:

• Subject with known active central nervous system (CNS) primary tumor or metastases.
• History of intercurrent severe chronic or active infections.
• Has a history of active autoimmune diseases .
• Has a history of symptomatic interstitial lung disease.
• Toxicities of prior therapies have not been resolved to Grade ≤1 or baseline as per NCI-CTCAE v5.0, except for alopecia, skin hyperpigmentation, Grade 2 neuropathy and Grade 2 endocrinopathy that is well controlled by replacement therapy.
• Subjects with severe or uncontrolled cardiovascular disorder requiring treatment.
• Prior allogenic or autologous bone marrow transplantation or other solid organ transplantation.
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years .
• Evidence of clinically significant immunosuppression .
• Presence of uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures .
• Previously treated with the following anti-tumor therapy (prior to the first dose of TGI-6):
• \) Previous treated with any B7-H6-targeting therapy. 2) Chemotherapy, target therapy, immunotherapy, or other anticancer therapy within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment, except:
• Washout period for nitrosoureas or mitomycin is ≤6 weeks.
• ≤5 half-lives or 2 weeks (whichever is longer) for fluoropyrimidines or small-molecule targeted agents.
• Washout period for herbal therapy with anticancer indications is ≤2 weeks. 3) Prior radiotherapy ≤4 weeks prior to the first dose of study treatment, with the exception of a single fraction of radiotherapy for the purposes of palliation, which is permitted.

Sponsors & Collaborators

• Hefei TG ImmunoPharma Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Xiaohu Zheng, Doctorate

CONTACT

+86 0551-62861151; xiaohu.zheng@tgimmunopharma.com

Hang Zhou, Bachelor

CONTACT

+86 0551-62861151; hang.zhou@tgimmunopharma.com

Study Design

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

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 18, 2024
• Study Start: January 3, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)