A Phase 1/2, Open-Label, Multi-Center, Dose Escalation and Expansion Study Evaluating the Safety, Tolerability and Clinical Activity of DECOY20 as Monotherapy and in Combination With Tislelizumab in Patients With Advanced Solid Tumors

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

INDP-D101 is a Phase 1/2, open-label, multi-center, dose escalation and expansion study evaluating the safety, tolerability and clinical activity of Decoy20 as monotherapy and in combination with tislelizumab in patients with locally advanced or metastatic solid tumors.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Males or females, age 18 years or older.

• Histologically confirmed diagnosis of locally advanced or metastatic solid tumor. For Part 2, subjects must have one of the following locally advanced or metastatic tumor types: hepatocellular carcinoma (HCC), colorectal cancer (CRC) with liver metastasis, urothelial cancer, squamous cell carcinoma of the head and neck (SCCHN), adenocarcinoma of the pancreas, non-small cell lung cancer (NSCLC), dMMR/MSI-High tumor (Part 2c only).

• Subject must have exhausted all available therapy or have declined treatment or treatment is contraindicated. Subjects with tumors that have known actionable molecular alteration such as EGFR, ALK, ROS-1, BRAF, RET, MET, and KRAS must have progressed on directed molecular therapy. For Part 2c, participants with a tumor type for which a CPI has been approved must have received a CPI during one or more lines of therapy.

• Measurable disease (at least 1 measurable lesion) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as defined by tumor type.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Life expectancy of at least 3 months.

• Female subjects must be of non-childbearing potential (surgically sterile or at least 2 years postmenopausal) or agree to use a highly effective contraception method while receiving treatment with Decoy20 and for 30 days after the last dose of Decoy20.

• Male subjects must utilize reliable contraceptive precautions for the duration of Decoy20 treatment and 30 days after the last dose of Decoy20.

• Adequate organ function as demonstrated by baseline laboratory assessment.

⁃ Left ventricular ejection fraction (LVEF) ≥ 45% by echocardiogram (ECHO) or multi-gated acquisition scan (MUGA).

⁃ Recovered from toxicities due to prior therapies.

⁃ Willing and able to comply with all scheduled visits, laboratory tests, and other study procedures including mandatory pre-treatment and on- treatment biopsies for subjects enrolled to Part2.

Locations
United States
California
University of Southern California- Norris Cancer Center
RECRUITING
Los Angeles
Hoag Memorial Hospital Presbyterian
RECRUITING
Newport Beach
Georgia
Winship Cancer Institute of Emory University
RECRUITING
Atlanta
Michigan
The Barbara Ann Karmanos Cancer Institute
RECRUITING
Detroit
Missouri
Washington University, Siteman Cancer Center
RECRUITING
St Louis
New Jersey
Atlantic Health System
RECRUITING
Morristown
New York
Roswell Park Comprehensive Cancer Center
RECRUITING
Buffalo
Ohio
Gabrail Cancer & Research Center
RECRUITING
Canton
Cleveland Clinic Taussig Cancer Center
RECRUITING
Cleveland
UH Seidman Cancer Center
RECRUITING
Cleveland
Pennsylvania
Fox Chase Cancer Center
RECRUITING
Philadelphia
South Carolina
Prisma Health Cancer Institute-ITOR
RECRUITING
Greenville
Contact Information
Primary
Indaptus Therapeutics
D101@indaptusrx.com
1-800-208-3508
Time Frame
Start Date: 2023-02-28
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 120
Treatments
Experimental: Part 1
A single dose of Decoy20 at a dose of 3 x 10\^7 KB or 7 x 10\^7 KB
Experimental: Parts 2a and 2b
Decoy20 administered weekly at a dose of 3 x 10\^7 KB or 7 x 10\^7 KB
Experimental: Part 2c
Decoy20 administered weekly at either 3 x 10\^7 KB or 7 x 10\^7 KB. Both will be administered with tislelizumab at 200mg Q3W.
Sponsors
Collaborators: Translational Drug Development
Leads: Indaptus Therapeutics, Inc

This content was sourced from clinicaltrials.gov

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