285 Participants NeededMy employer runs this trial

STRO-006 for Cancer

Recruiting at 6 trial locations
SC
Overseen BySutro Clinical Team
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cancer treatment called STRO-006 to determine its safety and effectiveness for individuals with certain cancers, such as lung, breast, or colorectal cancer, that have recurred or spread after other treatments. The study consists of three parts: administering STRO-006 alone, determining the optimal dose, and testing it in combination with pembrolizumab, an immunotherapy drug. Individuals with solid tumors unresponsive to standard treatments may qualify for this trial. As a Phase 1 trial, this research focuses on understanding how STRO-006 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that STRO-006 appears safe. Early studies suggest it is generally well-tolerated, meaning most people can handle it without serious problems. These studies also found that STRO-006 effectively fights tumors with limited side effects directly related to the treatment.

When combined with pembrolizumab, another cancer treatment, the safety remains promising. Pembrolizumab is commonly used in cancer treatments and is usually safe, but about 31.7% of patients have experienced serious side effects.

In this early-stage trial, researchers continue to study the safety of STRO-006 both alone and with pembrolizumab. While current studies offer some reassurance, a complete understanding of its safety will emerge as more research data is collected.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about STRO-006 for cancer because it represents a novel approach compared to traditional therapies like chemotherapy and radiation. Unlike standard treatments, which often attack both healthy and cancerous cells, STRO-006 is designed to precisely target cancer cells, potentially reducing side effects. Additionally, one part of the trial explores combining STRO-006 with pembrolizumab, an immunotherapy drug, which could enhance the body's immune response against cancer. This dual approach aims to improve treatment efficacy by harnessing the power of the immune system alongside targeted therapy.

What evidence suggests that STRO-006 might be an effective treatment for cancer?

Research has shown that STRO-006 demonstrates strong and lasting effects against tumors in early studies. It targets a protein called ITGB6, often found in certain tumors, which might help stop cancer cells from growing. Early results suggest it is safe and has few side effects. In this trial, some participants will receive STRO-006 as monotherapy, while others will receive it in combination with pembrolizumab, a well-known cancer treatment. Pembrolizumab has helped people with advanced cancers live longer. Combining these treatments could offer a new way to fight cancer by boosting the body's immune system.678910

Who Is on the Research Team?

JO

Jennifer Oliver

Principal Investigator

Sutro Biopharma

Are You a Good Fit for This Trial?

This trial is for adults with advanced or recurring solid tumors (like lung, esophageal, colorectal, endometrial, bladder, breast, stomach, or throat cancer) that have not responded to standard treatments. Participants must be in generally stable health aside from their cancer.

Inclusion Criteria

Life expectancy of at least 3 months
Willingness and ability to comply with the study protocol and long-term follow-up (LTFU) assessments
I can join regardless of how many treatments I've had before.
See 8 more

Exclusion Criteria

Concurrent participation in another therapeutic treatment trial
I have had a solid organ or bone marrow transplant.
I have untreated or active cancer that has spread to my brain or spinal fluid.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Part 1A)

Dose escalation of STRO-006 monotherapy to determine safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity

8-12 weeks

Dose Expansion (Part 1B)

Dose expansion to further evaluate STRO-006 monotherapy dose and determine the recommended Phase 2 dose

8-12 weeks

Combination Dose Escalation (Part 1C)

Combination dose escalation of STRO-006 with pembrolizumab to determine safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Pembrolizumab
  • STRO-006

Trial Overview

Researchers are testing a new drug called STRO-006 alone and in combination with pembrolizumab to find the safest dose and see how well it works against certain cancers. The study has several parts focusing on safety and early signs of effectiveness.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Part 1C STRO-006 in combination with pembrolizumabExperimental Treatment2 Interventions
Group II: Part 1B STRO-006 monotherapyExperimental Treatment1 Intervention
Group III: Part 1A STRO-006 monotherapyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sutro Biopharma, Inc.

Lead Sponsor

Trials
7
Recruited
1,100+

Citations

Long-Term KEYNOTE-006 Data Support Pembrolizumab ...

Patients who received pembrolizumab (n = 159) experienced a median overall survival (OS) of 32.7 months (95% CI, 24.5-41.6) vs 15.9 months (95% ...

KEYNOTE-006 - Clinical Trial Results | HCP - Keytruda

The reactions resolved in 79% of the 38 patients. Immune-mediated dermatologic adverse reactions occurred in 1.6% (4/251) of patients receiving KEYTRUDA QLEX in ...

New KEYTRUDA® (pembrolizumab) Data from KEYNOTE- ...

Long-term OS data showed an estimated 40 percent of patients were alive three years after starting treatment with KEYTRUDA (pembrolizumab), ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31345627/

Pembrolizumab versus ipilimumab in advanced melanoma ...

median overall survival was 32·7 months in the combined pembrolizumab groups and 15·9 months. Median progression-free survival was 8·4 months

Cost-Effectiveness of Pembrolizumab Versus Ipilimumab in ...

RESULTS: In the base case, pembrolizumab was projected to increase the life expectancy of U.S. patients with advanced melanoma by 1.14 years, ...

Pembrolizumab versus ipilimumab for advanced melanoma

24-month overall survival rate was 55% in the 2-week group, 55% in the 3-week group, and 43% in the ipilimumab group.

Updated Results Confirm Benefits of Adjuvant ...

An updated RFS analysis showed that at a median of 3.5 years, RFS rates were 59.8% in the pembrolizumab arm and 41.4% in the placebo arm (HR, 0.59; P <.001) in ...

Metastatic Melanoma Long-Term Survival Data

pembrolizumab continued to show improved overall survival vs ipilimumab in the 5-year follow-up. There were about 43% of patients estimated to ...

Pembrolizumab versus ipilimumab in advanced melanoma ...

median overall survival was 32·7 months (95% CI 24·5–41·6) in the combined pembrolizumab groups and 15·9 months (13·3–22·0)

Pembrolizumab Utilization and Clinical Outcomes Among ...

The results of this study show that pembrolizumab was associated with favorable outcomes in real-world patients with advanced melanoma, similar to other real- ...