Phase 1/2 Study of OBI-999 in Patients With Advanced Solid Tumors

NCT04084366 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: OBI-999-001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of OBI-999 as monotherapy, and to characterize the safety and preliminary clinical activity profile of the RP2D of OBI-999 in patients with advanced solid tumors.

Conditions

Locally Advanced Solid Tumor

Keywords

antibody drug conjugate (ADC)

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) (CR+PR)

  Assessment of OBI-999 clinical benefit rate for dose escalation and cohort expansion phases of the OBI 999-001 study.

  Every 6 weeks (±7 days) for first 3 months, then every 9 weeks (±7 days) until discontinuation of study treatment, disease progression, death, or initiation of further cancer therapy, or for up to 35 cycles (approximately 2 years.), whichever occurs first

Study Arms (2)

OBI-999 Escalation phase

EXPERIMENTAL

Part A: Five cohorts at escalating dose levels 0.4, 0.8, 1.2, 1.6 and 2.0 mg/kg (capping calculations at a maximum at 100 kg) of OBI-999 liquid form via IV infusion to establish maximum tolerated dose (MTD) and Recommended phase 2 dose (RP2D).

Drug: OBI-999

OBI-999 Expansion Phase

EXPERIMENTAL

Part B: Five cohorts of patients at RP2D of OBI-999 liquid form, as determined from Part A, via IV infusion.

Drug: OBI-999

Interventions

OBI-999 DRUG

For the dose-escalation phase, OBI-999 will be administered on Day 1 of each 21-day cycle, for up to 35 cycles.

OBI-999 Escalation phase

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 patients, 18 years of age or older at the time of consent.
• Provide written informed consent prior to performing any study related procedure.
• Histologically or cytologically confirmed patients with advanced solid tumors.
• Patients 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 informed consent must state the effective therapies the patient is declining.
• Measurable disease (i.e., at least one measurable lesion per RECIST 1.1)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ function defined as:
• a. Hepatic:
• i. Serum ALT ≤3 × upper limit of normal (ULN), ≤5 × ULN in the presence of liver metastases
• ii. Serum AST ≤3 × ULN, ≤5 × ULN in presence of liver metastases
• iii.Serum bilirubin ≤1.5 × ULN (unless due to Gilbert's syndrome or hemolysis)
• b. Renal:
• i. Creatinine clearance \>50 mL/minute using Cockcroft Gault equation
• c. Hematologic:
• i. Absolute neutrophil count ≥1,500/µL

You may not qualify if:

• 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 999.
• 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 999.
• Sensory or motor neuropathy of Grade 2 or greater.
• Patients with a history of solid organ transplant.
• Receipt of any prior therapy targeting Globo H.
• Known hypersensitivity to OBI 999 or its excipients.
• Has known untreated central nervous system metastases. Patients 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.
• Has significant clinical cardiac abnormality (e.g., clinical heart failure or unstable angina)
• Any medical co morbidity that is life threatening or, in the opinion of the Investigator, renders the patient unsuitable for participation in a clinical trial due to possible noncompliance, would place the patient at an unacceptable risk and/or potential to affect interpretation of results of the study.
• Is receiving any concurrent prohibited medication

Sponsors & Collaborators

• OBI Pharma, Inc: lead

Study Sites (4)

Scripps MD Anderson Cancer Center

La Jolla, California, 92037, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

West Cancer Center

Germantown, Tennessee, 38138, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Tsimberidou AM, Vo HH, Beck J, Shia CS, Hsu P, Pearce TE. First-in-Human Study of OBI-999, a Globo H-Targeting Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors. JCO Precis Oncol. 2023 Jan;7:e2200496. doi: 10.1200/PO.22.00496.

  PMID: 36701651 DERIVED

Results Point of Contact

• Title: Dr. Wayne Saville, Chief Medical Officer
• Organization: OBI Pharma, Inc.

waynesaville@obipharmausa.com

619-537-7821

Study Officials

• Apostolia Tsimberidou, MD, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 10, 2019
• Study Start: November 25, 2019
• Primary Completion: October 27, 2023
• Study Completion: October 27, 2023
• Last Updated: March 26, 2025
• Results First Posted: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)