IKS014 in Advanced Solid Tumors That Express HER2

Part of paid clinical trials in Newport Beach, California.

Sponsor
Iksuda Therapeutics Ltd.
Study ID
NCT05872295
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • IKS014 — DRUG
    IKS014 is a human monoclonal antibody (Ab) targeting HER2 linked to monomethyl auristatin F (MMAF) cytotoxic agent.

Study Details

This study will evaluate the recommended dose for further clinical development, safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS014, a HER2 targeting antibody-drug conjugate, in patients with advanced solid tumors.

Key Dates

Start date
Sep 14, 2023
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

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

Arms

  • Experimental: Dose Escalation Cohort (Part 1)
    Each patient will receive repeat doses (by intravenous (IV) infusions) on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
  • Experimental: Dose Expansion: HER2+ Breast Cancer Participants
    Each patient will receive IKS014 at the recommended dose defined in Part 1 on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
  • Experimental: Dose Expansion: HER2 Low Breast Cancer Participants
    Each patient will receive IKS014 at the recommended dose defined in Part 1 on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
  • Experimental: Dose Expansion: HER2+ Gastric Cancer or Gastro-esophageal Junction Participants
    Each patient will receive IKS014 at the recommended dose defined in Part 1 on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
  • Experimental: Dose Expansion: HER2 Low Gastric Cancer or Gastro-esophageal Junction Participants
    Each patient will receive IKS014 at the recommended dose defined in Part 1 on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
  • Experimental: Dose Expansion: HER2 Solid Tumor Cancer Participants
    Each patient will receive IKS014 at the recommended dose defined in Part 1 on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.

Primary Outcome Measure

Recommended Phase 2 Dose (Part 1) [ Time Frame: Up to 24 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92663
Monica Mita, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Nancy Lin, MD (PRINCIPAL_INVESTIGATOR)
Tennessee OncologyNashvilleTennessee37203
Jeffrey Russell, MD (PRINCIPAL_INVESTIGATOR)
START Dallas - Fort WorthFort WorthTexas76104
Henry Xiong, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Newport Beach, CA

By condition
Breast cancerGastric cancer
By specialty
OncologyBreast oncologyWomen's healthGI oncology
By research site
Hoag Memorial Hospital Presbyterian· Newport Beach, CADana Farber Cancer Institute· Boston, MATennessee Oncology· Nashville, TNSTART Dallas - Fort Worth· Fort Worth, TX

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