A Study Evaluating OBI-902 in Participants With Advanced Solid Tumors

Not Applicable

Not yet recruiting

• Conditions: Advanced Solid Tumor
• Interventions: Drug: OBI-902

• Registration Number: NCT07124117
• Lead Sponsor: OBI Pharma, Inc

Brief Summary

This is a 2-part trial: Part A (Dose Escalation) is designed to establish the maximum tolerated dose (MTD) and putative recommended phase 2 dose of OBI-902 (study drug) as monotherapy. Part B (Cohort Expansion) is intended to determine the optimal RP2D and further characterize the safety and preliminary clinical activity profile of the OBI-902 RP2D in participants with advanced solid tumors.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-04
• Study First Submitted QC: 2025-08-08
• Last Update Submitted: 2025-08-08
• Study Start: 2025-08-11
• Study First Posted: 2025-08-15
• Last Update Posted: 2025-08-15
• Primary Completion: 2029-02-08
• Study Completion: 2029-02-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

1. Male or female participants, 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 participants with metastatic or advanced solid tumor that is not curable with local therapies

4. Participants must have been treated with established standard-of-care therapy, or physicians have determined that such established therapy is not sufficiently efficacious, or patients have declined to receive standard-of-care therapy. In the latter case, the source documentation must state the effective therapies the participant is declining.

5. Measurable disease (i.e., at least one measurable lesion per RECIST 1.1)

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

7. Adequate organ function defined as:

   a. Hepatic:

   i. Serum ALT ≤3 × upper limit of normal (ULN), ≤5 × ULN in the presence of liver metastases

   i. Serum AST ≤3 × ULN, ≤5 × ULN in presence of liver metastases

   ii. Serum bilirubin ≤1.5 × ULN (unless due to Gilbert's syndrome (typically elevated total bilirubin of 1-5 mg/dL with a normal direct bilirubin) or hemolysis)

   b. Creatinine clearance >60 mL/minute using Modification of Diet in Renal Disease equation

   c. Hematologic:

   i. ANC ≥1,500/µL (>1,200/µL in Duffy antigen-null participants)

   ii. Platelets ≥100,000/µL

   iii. Hemoglobin ≥8 g/dL

8. Participants must be willing and able to comply with all protocol-required assessments, visits, and procedures, including pretreatment tumor biopsy. Archival tumor biopsies are acceptable at baseline. Each biopsy slide shall include ≥ 100 tumor cells.

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 7 months following the last dose of study drug.

10. Participants 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 participants must agree to use an adequate method of contraception during the study treatment period and for at least 4 months following the last dose of study drug.

11. Cannot be breast feeding.

12. Participants with human immunodeficiency virus (HIV) infection are eligible if CD4+ T-cell counts ≥350 cells/μL; participants on 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.

13. Participants with serological evidence of chronic HBV infection are eligible if they have an HBV viral load below the limit of quantification with or without concurrent viral suppressive therapy.

14. Participants with a history of HCV infection can be under curative antiviral treatment and have a viral load below the limit of quantification.

15. Participants in Part B (Cohort Expansion) - must have one of the following tumor types to be enrolled in the respective cohort:

    • Cohort 1: Relapsed/refractory HER2-negative BC
    • Cohort 2: Relapsed/refractory EC
    • Cohort 3: Relapsed/refractory intra- or extrahepatic CCA

Exclusion Criteria

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-902.
2. Participants that have undergone a major surgical procedure (as defined by the Investigator) or significant traumatic injury within 28 days prior to the first dose of OBI-902.
3. Sensory or motor neuropathy of Grade 2 or greater.
4. Participants with a history of solid organ transplant. Corneal transplant without immunosuppressive therapy is allowed.
5. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to Grade 0 or 1 (using NCI CTCAE version 5.0), except for alopecia and laboratory values listed in the inclusion criteria.
6. Receipt of any prior therapy targeting TROP2. (Phase 2 only)
7. Corrected QT interval (QTcF) prolongation to >470 msec based on the average of the screening 12-lead ECGs
8. Known hypersensitivity to OBI-902 or its excipients.
9. Participants with known untreated central nervous system (CNS) metastases. Participants 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.
10. Participants with significant clinical cardiac abnormality (e.g., clinical heart failure or unstable angina).
11. Any medical comorbidity that is life-threatening or, in the opinion of the Investigator, renders the participant unsuitable for participation in a clinical trial due to possible noncompliance, would place the participant at an unacceptable risk and/or potential to affect interpretation of results of the study.
12. Is receiving any concurrent prohibited medications as listed in OBI-902-001 clinical protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 1 Dose Escalation: Cohort 1	OBI-902	OBI-902 at dose level 1.6 mg/kg, Q3W
Phase 1 Dose Escalation: Cohort 2	OBI-902	OBI-902 at dose level 3.0 mg/kg, Q3W
Phase 1 Dose Escalation: Cohort 3	OBI-902	OBI-902 at dose level 4.5 mg/kg, Q3W
Phase 1 Dose Escalation: Cohort 4	OBI-902	OBI-902 at dose level 6.0 mg/kg, Q3W
Phase 1 Dose Escalation: Cohort 5	OBI-902	OBI-902 at dose level 8.0 mg/kg, Q3W
Phase 1 Dose Escalation: Cohort 6	OBI-902	OBI-902 at dose level 10.0 mg/kg, Q3W
Phase 2 Cohort Expansion: Cohort 1A	OBI-902	A randomized dosage optimization cohort for relapsed/refractory HER2-negative breast cancer participants
Phase 2 Cohort Expansion: Cohort 1B	OBI-902	A randomized dosage optimization cohort for relapsed/refractory HER2-negative breast cancer participants
Phase 2 Cohort Expansion: Cohort 2	OBI-902	OBI-902 at putative RP2D; relapsed/refractory Endometrial carcinoma cohort
Phase 2 Cohort Expansion: Cohort 3	OBI-902	OBI-902 at putative RP2D; Intra- and extrahepatic cholangiocarcinoma cohort

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD) and optimal recommended phase 2 dose (RP2D) of OBI-902	Duration of study, up to 54 weeks	To determine the MTD and optimal RP2D of OBI-902 using randomized assignment to 2 dose level cohorts and assessment of activity, safety, and tolerability for each cohort
Preliminary clinical activity profile of OBI-902 - DCR (disease control rate)	Duration of study, up to 54 weeks	Percentage of participants with DCR according to RECIST version 1.1 for each cohort
Safety and tolerability of OBI-902: incidence of adverse events (AEs), serious adverse events (SAEs), and laboratory abnormalities	Duration of study, up to 54 weeks	To determine the safety and tolerability of OBI-902 when administered intravenously to participants with advanced solid tumors, as graded by NCI CTCAE version 5.0
Preliminary clinical activity profile of OBI-902 - objective response rate (ORR)	Duration of study, up to 54 weeks	Percentage of participants with ORR according to RECIST version 1.1 for each cohort
Preliminary clinical activity profile of OBI-902 - CBR (clinical benefit rate)	Duration of study, up to 54 weeks	Percentage of participants with CBR according to RECIST version 1.1 for each cohort

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	Duration of study, up to 54 weeks	To evaluate the PFS
Duration of Response (DOR)	Duration of study, up to 54 weeks	To evaluate the DOR
Overall survival	Duration of study and 1 year safety follow up, up to 106 weeks	To evaluate the OS
Pharmacokinetics (PK) of OBI-902 and exatecan: Peak Plasma Concentration (Cmax)	Duration of study, up to 54 weeks	To evaluate the serum Cmax of OBI-902 and exatecan
Pharmacokinetics (PK) of OBI-902 and exatecan: area under the concentration-time curve (AUC)	Duration of study, up to 54 weeks	To evaluate the serum AUC of OBI-902 and exatecan
Pharmacokinetics (PK) of OBI-902 and exatecan: half-life (T1/2)	Duration of study, up to 54 weeks	To evaluate the serum half-life of OBI-902 and exatecan
Pharmacokinetics (PK) of OBI-902 and exatecan: clearance (CL)	Duration of study, up to 54 weeks	To evaluate the serum clearance of OBI-902 and exatecan
Pharmacokinetics (PK) of OBI-902 and exatecan: volume distribution at steady state (Vdss)	Duration of study, up to 54 weeks	To evaluate the serum volume distribution at steady state of OBI-902 and exatecan
Immunogenicity of OBI-902	Duration of study, up to 54 weeks	To evaluate the immunogenicity of OBI-902 anti-drug antibodies (ADAs)

Trial Locations

Locations (6)

Scripps Green Hospital; 🇺🇸 La Jolla, California, United States

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

NEXT Oncology; 🇺🇸 San Antonio, Texas, United States

Wan Fan Hospital; 🇨🇳 Taipei, Wenshan, Taiwan

Shuang Ho Hospital; 🇨🇳 Taipei, Zhonghe, Taiwan

China Medical University Hospital; 🇨🇳 Taichung, Taiwan