Study of OB-002 in Patients With Refractory Metastatic Cancer

NCT05940844 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: OB-002-101
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an open-label, non-randomized trial with OB-002 monotherapy dose escalation followed by a dose expansion in patients with metastatic colorectal, pancreatic, gastric, breast, or urothelial cancer who have progressed on two or more treatment regimens.

Conditions

Metastatic Cancer; Metastatic Colorectal Cancer; Metastatic Pancreatic Cancer; Metastatic Gastric Cancer; Metastatic Breast Cancer; Metastatic Urothelial Carcinoma

Keywords

solid tumors; CCR5

Outcome Measures

Primary Outcomes (2)

• Safety: adverse events

  Number of patients experiencing adverse events (AEs), serious AEs (SAEs) abnormalities in clinical laboratory tests, vital signs, electrocardiograms (ECGs), and physical exams

  From date of screening until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

• Safety: Maximum Tolerated Dose

  MTD will be defined on the basis of dose-limiting toxicities (DLTs)

  From date of first infusion with 28 days observation period (+/-3 days)

Secondary Outcomes (7)

• (PK) Pharmacokinetics Cmax

  samples are collected from first to fourth infusion (period of 28 days +/- 2 days)

• (PK) Pharmacokinetics Tmax

  samples are collected from first to fourth infusion (period of 28 days +/- 2 days)

• (PK) Pharmacokinetics AUC0-t

  samples are collected from first to fourth infusion (period of 28 days +/- 2 days)

• (PK) Pharmacokinetics AUC0 ∞

  samples are collected from first to fourth infusion (period of 28 days +/- 2 days)

• (PK) Pharmacokinetics t1/2

  samples are collected from first to fourth infusion (period of 28 days +/- 2 days)

Other Outcomes (13)

• Exploratory: immunogenicity of OB-002

  From first infusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

• Exploratory: evaluation of receptor occupancy (RO) of OB-002 in blood

  samples are collected from first to fourth infusion (period of 28 days +/- 2 days)

• Exploratory: evaluation of receptor occupancy (RO) of OB-002 in tumor

  samples are collected from first to fourth infusion (period of 28 days +/- 2 days)

Study Arms (5)

open label OB-002 monotherapy 0.25 mg/kg

EXPERIMENTAL

Dose Level 1

Drug: OB-002

open label OB-002 monotherapy 0.5 mg/kg

EXPERIMENTAL

Dose Level 2

Drug: OB-002

open label OB-002 monotherapy 1.0 mg/kg

EXPERIMENTAL

Dose Level 3

Drug: OB-002

open label OB-002 monotherapy 1.5 mg/kg

EXPERIMENTAL

Dose Level 4

Drug: OB-002

open label OB-002 monotherapy expansion cohort

EXPERIMENTAL

Dose Expansion

Drug: OB-002

Interventions

OB-002 DRUG

The patients will be dosed once weekly (Days 1, 8, 15 and 22) over a 4-week treatment cycle with a 28 day dose-limiting toxicity (DLT) observation period.

open label OB-002 monotherapy 0.25 mg/kg; open label OB-002 monotherapy 0.5 mg/kg; open label OB-002 monotherapy 1.0 mg/kg; open label OB-002 monotherapy 1.5 mg/kg; open label OB-002 monotherapy expansion cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Patients at least 18 years of age on the day of providing consent.
• Patients with accessible metastatic lesions for repetitive biopsy retrieval.
• Patients with histologically or cytologically confirmed metastatic colorectal, pancreatic, gastric, breast, or urothelial tumors who have progressed or were intolerant after two or more regimens and for whom no standard of care or curative therapy options are available.
• Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 within 7 days of the start of treatment
• Patients with evaluable and measurable lesions as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
• Patients with adequate organ function at the time of enrollment as defined below:
• Neutrophil count ≥1500/mm3
• Platelet count ≥7.5 × 105/mm3
• Hemoglobin \>9.0g/dL (transfusion \>2 weeks before testing permitted)
• Aspartate transaminase (AST), alanine transaminase (ALT)
• ≤2.5 × the upper limit of normal (ULN) (≤5-times in patients with liver metastasis)
• Total bilirubin ≤1.5 × ULN
• Creatinine clearance \>60 mL (determined by Cockcroft-Gault Equation)
• International normalized ratio (INR) ≤1.5 × ULN and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT)

You may not qualify if:

• Unwilling to undergo biopsy retrieval during screening (unless an archival sample taken within 3 months before screening is available) and after the fourth infusion of OB-002
• Note: Patients must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Patients with ≤Grade 2 neuropathy may be eligible. If patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
• Patients with a history of CCR5 antagonist therapy (e.g., vicriviroc, maraviroc).
• Patients with uncontrolled hypertension (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg) with treatment
• QTc interval greater than 450 msec (males) or 470 msec (females)
• Patients with acute coronary syndrome (including myocardial infarction and unstable angina), and with a history of coronary angioplasty or stent placement performed within 6 months before enrollment
• Patients with a large amount of pleural effusion or ascites requiring more than weekly drainage
• Patients with a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis.
• Patients with a ≥Grade 3 active infection according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
• Patients with symptomatic brain metastasis (1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system \[CNS\] disease)
• Patients with partial or complete gastrointestinal obstruction
• Patients with interstitial lung disease requiring treatment with systemic steroids or other agents
• Patients who test positive for either anti-human immunodeficiency virus type 1 (HIV-1) antibodies, hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (HCV) antibodies with a positive HCV RNA viral load test
• Patients with concurrent autoimmune disease, or a history of chronic or recurrent autoimmune disease
• Patients who require systemic corticosteroids equivalent to ≥10 mg prednisone (excluding temporary usage for tests, prophylactic administration for allergic reactions, or to alleviate swelling associated with radiotherapy) or immunosuppressants, or who have received such a therapy \<14 days before enrollment in the present study

Sponsors & Collaborators

• Orion Biotechnology Polska Sp. z o.o.: lead

MeSH Terms

Conditions

Neoplasm Metastasis; Colorectal Neoplasms; Pancreatic Neoplasms; Stomach Neoplasms; Breast Neoplasms; Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Stomach Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

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

Model Details: A total of up to 36 patients will be screened and 18 enrolled. At least 3 patients at each of the 4 dose levels (0.25, 0.5, 1.0, and 1.5 mg/kg planned) and up to 6 patients at the highest dose(s) if no MTD. An additional 3 patients may be recruited at any of the dose levels to define the dose(s) for further development. Each patient will be enrolled for at least one 28-day cycle of treatment with a FU period of up to 12 months.

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 11, 2023
• Study Start: January 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 9, 2025

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share