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ST-067-001 for Solid Tumors

Verified Trial

Phase 1

Recruiting

Research Sponsored by Simcha IL-18, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are you mobile and able to carry out light work throughout your day?

Have you been diagnosed with advanced or metastatic cancer (solid tumor) and received standard treatments?

Must not have

Have you been diagnosed with Hepatitis B, Hepatitis C, or HIV?

Have you received radiation therapy in the last two weeks or do you have radiation therapy planned?

Timeline

Screening 28 days

Treatment 24 months

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called ST-067 on patients with certain types of cancer that have not responded to previous treatments. The goal is to find the safest and most effective dose and to see how well it works against these cancers.

Who is the study for?

Adults (≥18 years) with advanced or metastatic cancer, including melanoma and lung cancer, who've progressed after standard therapy or for whom no survival-prolonging standard care is available. Participants must be able to perform light work (ECOG status of 0 or 1), have at least one measurable lesion not previously treated by biopsy or radiation, and an accessible tumor for required biopsies.

What is being tested?

The trial tests ST-067 as a subcutaneous injection alone and in combination with IV infusion obinutuzumab (Gazyva®) plus pembrolizumab (Keytruda). It's a multi-phase study starting with dose escalation to assess safety and preliminary effectiveness before moving on to Phase 2.

What are the potential side effects?

Potential side effects may include reactions at the injection site for ST-067, infusion-related reactions from obinutuzumab, and immune system-related adverse effects such as fatigue, skin issues, digestive disturbances from pembrolizumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can move around and do light tasks throughout the day.

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I have advanced cancer and have undergone standard treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with Hepatitis B, C, or HIV.

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I have not had radiation therapy in the last two weeks and do not have any planned.

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I do not have serious heart, breathing, adrenal gland, or autoimmune conditions.

Timeline

Screening ~ 28 days1 visit

Treatment ~ 24 months35 visits

Follow Up ~ 30 days1 visit

Screening ~ 28 days

Treatment ~ 24 months

Follow Up ~30 days

This trial's timeline: 28 days for screening, 24 months for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the maximum tolerated dose and recommended Phase 2 doese of ST-067 in phase 1a monotherapy

Evaluate the overall safety and tolerability of ST-067 in combination with pembrolizumab (Keytruda)

Number of Participants With Treatment-Related Adverse Events

+1 more

Secondary study objectives

To characterize the PK and PD profiles of ST-067 with pembrolizumab (Keytruda)

To characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of ST-067 as a single agent

To evaluate the antitumor activity of ST-067 and ST-067 in combination with pembrolizumab (Keytruda)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: ST-067 subcutaneous + pembrolizumab (Keytruda)Experimental Treatment2 Interventions

The Phase 1 Combination therapy is an open-label dose escalation study of ST-067 in combination with pembrolizumab (Keytruda) in subjects with solid tumors experiencing insufficient response to a checkpoint inhibitor (PD-1) therapy.The Phase 1 combination cohort will not open until the tolerability of a given ST-067 dose level has been confirmed safe in the monotherapy arm.

Group II: ST-067 subcutaneous + obinutuzumab (Gazyva) pre-treatmentExperimental Treatment2 Interventions

The starting dose for ST-067 with obinutuzumab (Gazyva) pre-treatment will be 120µg/kg. Obinutuzumab (Gazyva) will be administered at 1000 mg daily via IV infusion on 2 consecutive days, with the first dose given at least 7 days prior to first dose of SC ST-067.

Group III: ST-067 IV infusion monotherapyExperimental Treatment1 Intervention

The starting dose for the IV monotherapy dosing will be a dose that is modeled to have a maximum concentration observed that does not exceed the highest tolerated SC dose approved by the ISRC. ST-067 will be given on a weekly schedule when administered by the IV route of administration. Escalation decisions for the IV formulation will be based primarily on its emerging toxicity profile.

0 / 5Eligibility criteria met