ACTIVE_NOT_RECRUITING

Study of DECOY20 With or Without Tislelizumab in Patients With Advanced Solid Tumors

Conditions

Solid Tumor, Adult HCC - Hepatocellular Carcinoma CRC (Colorectal Cancer)Pancreatic Adenocarcinoma NSCLC Non-small Cell Lung Cancer Squamous Cell Cancer of the Head and Neck UC (Urothelial Cancer)MSI-H Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-02-28

Study Completion:2027-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05651022

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Males or females, age 18 years or older. 2. 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). 3. 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. 4. Measurable disease (at least 1 measurable lesion) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as defined by tumor type. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Life expectancy of at least 3 months. 7. 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. 8. Male subjects must utilize reliable contraceptive precautions for the duration of Decoy20 treatment and 30 days after the last dose of Decoy20. 9. Adequate organ function as demonstrated by baseline laboratory assessment. 10. Left ventricular ejection fraction (LVEF) ≥ 45% by echocardiogram (ECHO) or multi-gated acquisition scan (MUGA). 11. Recovered from toxicities due to prior therapies. 12. 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.	1. Pregnant or lactating females. 2. Has an active systemic (viral, bacterial, or fungal) infection or requiring treatment. 3. Received radiotherapy within 28 days of the first dose of Decoy20. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. 4. Received prior chemotherapy, targeted therapy or immunotherapy within 28 days or 5 half-lives from W1D1, whichever is shorter. 5. Received systemic corticosteroid therapy \> 5 mg/day of prednisone or equivalent dose of another corticosteroid within 1 week or 5 half-lives (whichever is shorter) from the start of study drug or is expected to require it during the course of the study (topical and inhaled steroids are permitted). 6. Has radiographically detected primary central nervous system (CNS) metastases or symptomatic CNS involvement (including leptomeningeal carcinomatosis, cranial neuropathies or mass lesions that cause spinal cord compression). Participants with brain metastases (either treated or deemed unnecessary to treat) that have been stable by neuroimaging for at least 4 weeks will be eligible. 7. Clinical evidence of significant coagulopathy during Screening (e.g., deep vein thrombosis or pulmonary embolism) or history of significant uncontrolled coagulopathy (participants with HCC must have prothrombin time (PT) \< 4 seconds above ULN or international normalized ratio \[INR\] \< 1.7) or participants with diagnosis of a new thrombotic event within 90 days prior to Decoy20 dosing. 8. Has an active secondary malignancy in addition to the primary, excluding low-risk neoplasms as determined by the Investigator (e.g., non-metastatic basal cell or squamous cell skin carcinoma) and other indolent malignancies will be allowed after discussion with the Sponsor). 9. Has a history of or active infection with HIV 1 or 2, a history of or active infection with HBV based upon HBV antigenemia or viral load, or positive read for hepatitis C virus (\[HCV\] viral load \>15 IU/mL) at Screening. 10. Has a history of known genetic predisposition to HLH/MAS.

Inclusion Criteria

Exclusion Criteria

1. Males or females, age 18 years or older.
2. 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).
3. 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.
4. Measurable disease (at least 1 measurable lesion) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as defined by tumor type.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Life expectancy of at least 3 months.
7. 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.
8. Male subjects must utilize reliable contraceptive precautions for the duration of Decoy20 treatment and 30 days after the last dose of Decoy20.
9. Adequate organ function as demonstrated by baseline laboratory assessment.
10. Left ventricular ejection fraction (LVEF) ≥ 45% by echocardiogram (ECHO) or multi-gated acquisition scan (MUGA).
11. Recovered from toxicities due to prior therapies.
12. 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.

1. Pregnant or lactating females.
2. Has an active systemic (viral, bacterial, or fungal) infection or requiring treatment.
3. Received radiotherapy within 28 days of the first dose of Decoy20. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
4. Received prior chemotherapy, targeted therapy or immunotherapy within 28 days or 5 half-lives from W1D1, whichever is shorter.
5. Received systemic corticosteroid therapy \> 5 mg/day of prednisone or equivalent dose of another corticosteroid within 1 week or 5 half-lives (whichever is shorter) from the start of study drug or is expected to require it during the course of the study (topical and inhaled steroids are permitted).
6. Has radiographically detected primary central nervous system (CNS) metastases or symptomatic CNS involvement (including leptomeningeal carcinomatosis, cranial neuropathies or mass lesions that cause spinal cord compression). Participants with brain metastases (either treated or deemed unnecessary to treat) that have been stable by neuroimaging for at least 4 weeks will be eligible.
7. Clinical evidence of significant coagulopathy during Screening (e.g., deep vein thrombosis or pulmonary embolism) or history of significant uncontrolled coagulopathy (participants with HCC must have prothrombin time (PT) \< 4 seconds above ULN or international normalized ratio \[INR\] \< 1.7) or participants with diagnosis of a new thrombotic event within 90 days prior to Decoy20 dosing.
8. Has an active secondary malignancy in addition to the primary, excluding low-risk neoplasms as determined by the Investigator (e.g., non-metastatic basal cell or squamous cell skin carcinoma) and other indolent malignancies will be allowed after discussion with the Sponsor).
9. Has a history of or active infection with HIV 1 or 2, a history of or active infection with HBV based upon HBV antigenemia or viral load, or positive read for hepatitis C virus (\[HCV\] viral load \>15 IU/mL) at Screening. 10. Has a history of known genetic predisposition to HLH/MAS.

Contacts and Locations

Principal Investigator

Indaptus Therapeutics

STUDY_DIRECTOR

Indaptus Therapeutics, Inc

Study Locations (Sites)

University of Southern California- Norris Cancer Center

Los Angeles, California, 90033

United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663

United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322

United States

The Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201

United States

Washington University, Siteman Cancer Center

St Louis, Missouri, 63108

United States

Atlantic Health System

Morristown, New Jersey, 07960

United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263

United States

Gabrail Cancer & Research Center

Canton, Ohio, 44718

United States

UH Seidman Cancer Center

Cleveland, Ohio, 44106

United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

United States

Prisma Health Cancer Institute-ITOR

Greenville, South Carolina, 29605

United States

Collaborators and Investigators

Sponsor: Indaptus Therapeutics, Inc

Indaptus Therapeutics, STUDY_DIRECTOR, Indaptus Therapeutics, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-28

Study Completion Date2027-09-30

Study Record Updates

Study Start Date2023-02-28

Study Completion Date2027-09-30

Terms related to this study

Additional Relevant MeSH Terms

Solid Tumor, Adult
HCC - Hepatocellular Carcinoma
CRC (Colorectal Cancer)
Pancreatic Adenocarcinoma
NSCLC Non-small Cell Lung Cancer
Squamous Cell Cancer of the Head and Neck
UC (Urothelial Cancer)
MSI-H Cancer