Clinical trial

An Open-Label Phase 1a/1b Dose-Escalation and Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors

Name

AB248-101

Description

This is a phase I, First-in-Human (FIH), open-label study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of AB248 as monotherapy OR in combination with pembrolizumab in adult participants with locally advanced or metastatic solid tumors. The study will consist of a dose escalation and a dose expansion stage.

Trial arms

Trial start

2023-01-04

Estimated PCD

2025-06-01

Trial end

2025-10-01

Status

Recruiting

Phase

Early phase I

Treatment

AB248

Intravenous infusion of AB248: CD8+ T cell selective interleukin-2 investigational drug

Arms:

AB248 + Pembrolizumab Combination Dose-Escalation, AB248 + Pembrolizumab Combination Indication Expansion, AB248 Monotherapy Dose-Escalation, AB248 Monotherapy Indication Expansion

Pembrolizumab

Intravenous infusion of pembrolizumab

Arms:

AB248 + Pembrolizumab Combination Dose-Escalation, AB248 + Pembrolizumab Combination Indication Expansion

Size

262

Primary endpoint

Frequency of Dose-Limiting Toxicities (DLTs)

From Study Day 1 through up to Day 21

Frequency of Serious Adverse Events (SAEs)

Signed consent up to 90 days after discontinuing study treatment

Frequency of Treatment Emergent Adverse Events (TEAEs)

Study Day 1 up to 90 days after discontinuing study treatment

Frequency of Adverse Events of Special Interest (AESIs)

Study Day 1 up to 90 days after discontinuing study treatment

Frequency of Adverse Events (AEs) leading to dose interruption or treatment discontinuation and death

Signed consent up to 90 days after discontinuing study treatment

Eligibility criteria

Inclusion Criteria: * Age ≥18 years of age at the time consent is signed. * Has adequate end organ function per laboratory testing. * Pregnancy prevention requirements * Has measurable disease per RECIST 1.1 as assessed by the local site Investigator/radiology. * Has a performance status of 0 or 1 on Eastern Cooperative Oncology Group scale. * Histologic documentation of incurable, locally advanced or metastatic tumor of the type being evaluated in individual cohorts Exclusion Criteria: * Has a diagnosis of immunodeficiency. * Has a history of a previous, additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years. * Has known active CNS metastases and/or carcinomatous meningitis. * Has an active autoimmune disease * Has an active infection requiring systemic therapy. * Inability to comply with study and follow-up procedures. * Has had a severe hypersensitivity reaction (Grade ≥3) to treatment with pembrolizumab, another monoclonal antibody, or has history of any hypersensitivity to any components of the study treatments or any of their excipients. * Has received prior systemic anticancer therapy including investigational agents within 4 weeks (or, if shorter, within 5 half-lives for kinase inhibitors) prior to first dose of study treatment. * Has received prior radiotherapy within 2 weeks of start of study treatment or has had a history of radiation pneumonitis. * Receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment. * Has received previous treatment with another agent targeting the IL-2, IL-7, or IL-15 receptors. * Is expected to require any other form of antineoplastic therapy while on study

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 262, 'type': 'ESTIMATED'}}

Updated at

2023-11-15

1 organization

2 products

5 indications

Product

AB248

Indication

Solid Tumor

Indication

Lung Cancer

Indication