ACTIVE_NOT_RECRUITING

A Phase 1/2 Study of OBI-992 in Subjects With Advanced Solid Tumors

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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

This is a 2-part trial: Part A (Dose Escalation) is designed to establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of OBI-992 (Anti-TROP2 antibody drug conjugate, anti-TROP2 monoclonal antibody-cleavable peptide linker-exatecan) as monotherapy. Part B (Cohort Expansion) is intended to further characterize the safety and preliminary clinical activity profile of the RP2D of OBI-992 in subjects with advanced solid tumors.

Official Title

A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-992 in Subjects With Advanced Solid Tumors

Quick Facts

Study Start:2024-06-12

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06480240

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. Male or female subjects, 18 years of age or older at the time of consent 2. Provide written informed consent prior to performing any study-related procedure 3. Histologically or cytologically confirmed subjects with metastatic or advanced solid tumor that is not curable with local therapies 4. Subjects must have been treated with established standard-of-care therapy, or physicians have determined that such established therapy is not sufficiently efficacious, or subjects have declined to receive standard-of-care therapy. In the latter case, the informed consent must state the effective therapies the subject is declining. 5. Measurable disease (i.e., at least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST 1.1\]) 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 7. Adequate organ function defined as: 8. Subjects are willing and able to comply with all protocol-required assessments, visits, and procedures, including pretreatment tumor biopsy. Archival tumor biopsies are acceptable at baseline. 9. Females of childbearing potential must have negative serum pregnancy test prior to starting study therapy and agree to use a reliable form of contraceptive during the study treatment period and for at least 120 days following the last dose of study drug. Subject not of childbearing potential (i.e., permanently sterilized, postmenopausal) can be included in the trial. Postmenopausal is defined as 12 months with no menses without an alternative medical cause. Male subjects must agree to use an adequate method of contraception during the study treatment period and for at least 120 days following the last dose of study drug. 10. Cannot be breast feeding 11. Subjects with human immunodeficiency virus (HIV) infection are eligible if CD4+ Tcell counts ≥ 350 cells/μL; subjects on anti-retroviral therapy (ART) should be on an established dose for at least 4 weeks and have an HIV viral load less than 200 copies/mL prior to enrollment. 12. Subjects with serological evidence of chronic hepatitis B virus (HBV) infection are eligible if they have an HBV viral load below the limit of quantification with or without concurrent viral suppressive therapy. 13. Subjects with a history of hepatitis C virus (HCV) infection can be under curative antiviral treatment and have a viral load below the limit of quantification. 14. Subjects in Part B (Cohort-Expansion) - must have one of the following tumor types to be enrolled in the respective cohort: * Cohort 1: Non-small cell lung cancer (NSCLC) * Cohort 2: Small cell lung cancer (SCLC) * Cohort 3: Gastric cancer	1. Less than 3 weeks from prior cytotoxic chemotherapy or radiation therapy; and less than 5 half-lives or 3 weeks, whichever is shorter, from prior biologic therapies, prior to the first dose of OBI-992 2. Has undergone a major surgical procedure (as defined by the Investigator) or significant traumatic injury within 28 days prior to the first dose of OBI-992 3. Sensory or motor neuropathy of Grade 2 or greater 4. Subjects with a history of solid organ transplant 5. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to Grade 0 or 1 (using National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 5.0), except for alopecia and laboratory values listed in the inclusion criteria 6. Corrected QT interval (QTcF) prolongation to \>470 msec based on the average of the screening 12-lead ECGs 7. Known hypersensitivity to OBI-992 or its excipients 8. Has known untreated central nervous system (CNS) metastases. Subjects with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging \[MRI\] or computed tomography \[CT\]) during the screening period 9. Has significant clinical cardiac abnormality (e.g., clinical heart failure or unstable angina) 10. Any medical comorbidity that is life-threatening or, in the opinion of the Investigator, renders the subject unsuitable for participation in a clinical trial due to possible noncompliance, would place the subject at an unacceptable risk (e.g. Interstitial lung disease (ILD)) and/or potential to affect interpretation of results of the study. 11. Subjects in Part B (Phase 2 Cohort Expansion) may not have had prior therapy with an approved or investigational TROP2 ADC (prior TROP2 ADC therapy allowed during dose escalation) 12. Is receiving any concurrent prohibited medications

Inclusion Criteria

Exclusion Criteria

1. Male or female subjects, 18 years of age or older at the time of consent
2. Provide written informed consent prior to performing any study-related procedure
3. Histologically or cytologically confirmed subjects with metastatic or advanced solid tumor that is not curable with local therapies
4. Subjects must have been treated with established standard-of-care therapy, or physicians have determined that such established therapy is not sufficiently efficacious, or subjects have declined to receive standard-of-care therapy. In the latter case, the informed consent must state the effective therapies the subject is declining.
5. Measurable disease (i.e., at least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST 1.1\])
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
7. Adequate organ function defined as:
8. Subjects are willing and able to comply with all protocol-required assessments, visits, and procedures, including pretreatment tumor biopsy. Archival tumor biopsies are acceptable at baseline.
9. Females of childbearing potential must have negative serum pregnancy test prior to starting study therapy and agree to use a reliable form of contraceptive during the study treatment period and for at least 120 days following the last dose of study drug. Subject not of childbearing potential (i.e., permanently sterilized, postmenopausal) can be included in the trial. Postmenopausal is defined as 12 months with no menses without an alternative medical cause. Male subjects must agree to use an adequate method of contraception during the study treatment period and for at least 120 days following the last dose of study drug.
10. Cannot be breast feeding
11. Subjects with human immunodeficiency virus (HIV) infection are eligible if CD4+ Tcell counts ≥ 350 cells/μL; subjects on anti-retroviral therapy (ART) should be on an established dose for at least 4 weeks and have an HIV viral load less than 200 copies/mL prior to enrollment.
12. Subjects with serological evidence of chronic hepatitis B virus (HBV) infection are eligible if they have an HBV viral load below the limit of quantification with or without concurrent viral suppressive therapy.
13. Subjects with a history of hepatitis C virus (HCV) infection can be under curative antiviral treatment and have a viral load below the limit of quantification.
14. Subjects in Part B (Cohort-Expansion) - must have one of the following tumor types to be enrolled in the respective cohort:
* Cohort 1: Non-small cell lung cancer (NSCLC)
* Cohort 2: Small cell lung cancer (SCLC)
* Cohort 3: Gastric cancer

1. Less than 3 weeks from prior cytotoxic chemotherapy or radiation therapy; and less than 5 half-lives or 3 weeks, whichever is shorter, from prior biologic therapies, prior to the first dose of OBI-992
2. Has undergone a major surgical procedure (as defined by the Investigator) or significant traumatic injury within 28 days prior to the first dose of OBI-992
3. Sensory or motor neuropathy of Grade 2 or greater
4. Subjects with a history of solid organ transplant
5. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to Grade 0 or 1 (using National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 5.0), except for alopecia and laboratory values listed in the inclusion criteria
6. Corrected QT interval (QTcF) prolongation to \>470 msec based on the average of the screening 12-lead ECGs
7. Known hypersensitivity to OBI-992 or its excipients
8. Has known untreated central nervous system (CNS) metastases. Subjects with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging \[MRI\] or computed tomography \[CT\]) during the screening period
9. Has significant clinical cardiac abnormality (e.g., clinical heart failure or unstable angina)
10. Any medical comorbidity that is life-threatening or, in the opinion of the Investigator, renders the subject unsuitable for participation in a clinical trial due to possible noncompliance, would place the subject at an unacceptable risk (e.g. Interstitial lung disease (ILD)) and/or potential to affect interpretation of results of the study.
11. Subjects in Part B (Phase 2 Cohort Expansion) may not have had prior therapy with an approved or investigational TROP2 ADC (prior TROP2 ADC therapy allowed during dose escalation)
12. Is receiving any concurrent prohibited medications

Contacts and Locations

Study Locations (Sites)

California Clinical Trials Medical Group (CCTMG)

Glendale, California, 91206

United States

Scripps Green Hospital

La Jolla, California, 92037

United States

Karmanos Cancer Institute

Detroit, Michigan, 48201

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

NEXT Oncology

San Antonio, Texas, 78229

United States

NEXT Virginia

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: OBI Pharma, 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 Date2024-06-12

Study Completion Date2027-06

Study Record Updates

Study Start Date2024-06-12

Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

Advanced Solid Tumor