Study to Evaluate Safety & Tolerability of AGI-134 in Solid Tumour

Recruiting in Palo Alto (17 mi)

+13 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Agalimmune Ltd.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study will evaluate if AGI-134 given alone is safe and tolerate in treating patients with unresectable/metastatic solid tumours.

Research Team

Eligibility Criteria

Inclusion Criteria

Evaluable Disease according to RECIST v1.1

Has ≥1 injectable lesion which is amenable to injection and biopsy and is measurable according to RECIST v1.1.

Has ≥1 metastatic lesion is amenable for biopsy and measurable according to RECIST v1.1

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Treatment Details

Interventions

AGI-134 (Other)

Participant Groups

4Treatment groups

Experimental Treatment

Group I: AGI-134 50 mgExperimental Treatment1 Intervention

50 mg AGI-134 (2 mL) via intratumor injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.

Group II: AGI-134 25 mgExperimental Treatment1 Intervention

25 mg AGI-134 (1 mL) via intratumor injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.

Group III: AGI-134 200 mgExperimental Treatment1 Intervention

200 mg AGI-134 (8 mL) via intratumor injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.

Group IV: AGI-134 100 mgExperimental Treatment1 Intervention

100 mg AGI-134 (4 mL) via intratumor injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.