A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-999 in Patients With Advanced Solid Tumors

OBI Pharma, Inc4 sites in 1 country44 target enrollmentNovember 25, 2019

ConditionsLocally Advanced Solid Tumor

InterventionsOBI-999

DrugsOBI-999

Overview

Phase: Phase 1
Intervention: OBI-999
Conditions: Locally Advanced Solid Tumor
Sponsor: OBI Pharma, Inc
Enrollment: 44
Locations: 4
Primary Endpoint: Objective Response Rate (ORR) (CR+PR)
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 25, 2019

End Date

October 27, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

OBI Pharma, Inc

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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
•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
•Sensory or motor neuropathy of Grade 2 or greater.
•Patients with a history of solid organ transplant.
•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.
•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.

Arms & Interventions

OBI-999 Escalation phase

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).

Intervention: OBI-999

OBI-999 Expansion Phase

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

Intervention: OBI-999

Outcomes

Primary Outcomes

Objective Response Rate (ORR) (CR+PR)

Time Frame: 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

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