ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)

Part of paid clinical trials in San Diego, California.

Sponsor
Acepodia Biotech, Inc.
Study ID
NCT06415487
Phase
PHASE1
Status
Recruiting
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Conditions

  • Locally Advanced Solid Tumor
  • Metastatic Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Lymphodepleting agent
  • Fludarabine — DRUG
    Lymphodepleting agent
  • ACE2016 — DRUG
    Allogeneic gamma delta T (gdT) cell therapy
  • Pembrolizumab — DRUG
    Immune checkpoint anti-PD-1 antibody

Study Details

ACE2016 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment of Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR). The ACE2016-001 study is an open-label, Phase I, first-in-human (FIH) study that aims to evaluate the safety and tolerability, persistency, pharmacodynamics and efficacy of ACE2016 in patients with Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR).

Key Dates

Start date
Aug 22, 2024
Status verified
Jun 2025
Primary completion
Dec 31, 2026
Completion
Mar 27, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: ACE2016 ONLY: 1 DOSE
    ACE2016 dose escalation, monotherapy. Lymphodepleting regimen followed by escalating doses of ACE2016.
  • Experimental: ACE2016 ONLY: 3 DOSES
    ACE2016 recommended dose, monotherapy. Lymphodepleting regimen followed by recommended dose of ACE2016.
  • Experimental: ACE2016 AND PEMBROLIZUMAB: 3 DOSES
    ACE2016 recommended dose, in combination with pembrolizumab. Lymphodepleting regimen followed by recommended dose of ACE2016, giving in combination with pembrolizumab.

Primary Outcome Measure

Incidence of DLTs, AESIs, Grade 3 or higher TEAEs, TEAEs considered related to ACE2016, TEAEs resulting in death, SAEs, related SAEs, and TEAEs leading to treatment discontinuation will be summarized by cohort [ Time Frame: 1 year ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of California San DiegoSan DiegoCalifornia92093
Moores Cancer Center
Sandip Patel, MD (PRINCIPAL_INVESTIGATOR)
SCRI Denver Drug Development UnitDenverColorado80218
James Vick
Jason Henry, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research Institute (SCRI) Oncology PartnersNashvilleTennessee37203
Emily Lay Petcu
Meredith Pelster, MD (PRINCIPAL_INVESTIGATOR)
Texas OncologyDallasTexas75246
Texas Oncology
Scott Paulson, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Diego, CA

By research site
University of California San Diego· San Diego, CASCRI Denver Drug Development Unit· Denver, COSarah Cannon Research Institute (SCRI) Oncology Partners· Nashville, TNTexas Oncology· Dallas, TX

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