A Dose Escalation and Expansion Study of GIGA-564 in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGigaGen, Inc.

About this trial

The purpose of this study is to assess the safety and tolerability of GIGA-564 and identify the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) level(s) of GIGA-564 in participants with metastatic or locally advanced solid tumor malignancies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Willing and able to provide informed consent.

Histologically or cytologically confirmed locally advanced or radiographically confirmed metastatic solid tumor malignancies ineligible for standard-of-care or refractory to or relapsing after at least one line of systemic therapy in the metastatic or advanced setting.

Measurable disease on imaging as based on Response Evaluation Criteria in RECIST 1.1.

Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.

Disqualifiers

Investigational therapy and/or anti-cancer therapy with the potential for late onset toxicity within 4 weeks or 5 half-lives (whichever is shorter), or nitrosoureas or mitomycin C within 6 weeks. Food and drug administration (FDA)-approved hormonal therapies (e.g., androgen deprivation therapy [ADT] for prostate cancer, anti-estrogen for breast cancer, somatostatin analogue for neuroendocrine cancer) are allowed.

Failure to resolve toxicity from previous anti-cancer therapy (other than National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v5.0 ≤ Grade 2 alopecia, neuropathy or medically controlled endocrinopathies) to NCI CTCAE v5.0 ≤ Grade 1.

Prior receipt of therapy directed against CTLA-4.

Prior receipt of therapy directed against chemokine (C-C motif) receptor 8 (CCR8), cluster of differentiation 25 (CD25), or T cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibition motif domains (TIGIT) with an active Fc domain.

Trial design

Design model

Sequential

Treatments tested in this trial

  • GIGA-564

    Drug

    Administered by intravenous infusion

  • GIGA-564

    Drug

    Administered by intravenous infusion

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: GIGA-564: Dose Escalation (Phase 1A)Experimental treatment 1 intervention
Group B: GIGA-564: Dose Expansion (Phase 1B)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Time frame
Up to 154 days
2

Number of Participants With Grade 3 or 4 TEAEs

Time frame
Up to 154 days
3

Number of Participants With Treatment-related TEAEs

Time frame
Up to 154 days
4

Number of Participants With Grade 3 or 4 Treatment-related TEAEs

Time frame
Up to 154 days

Secondary outcomes

1

Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Time frame
Up to Week 24
2

Percentage of Participants with Minor RECIST 1.1 Response

Time frame
Up to Week 24
3

Disease Control Rate (DCR) per RECIST 1.1

Time frame
Up to Week 24
4

Progression Free Survival (PFS)

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GigaGen, Inc.

Lead sponsor

National Cancer Institute (NCI)

Collaborator