Is NCT06956690 recruiting in San Antonio, TX?

Yes, NCT06956690 is currently recruiting participants at its San Antonio, TX location. This solid tumors clinical trial is actively enrolling qualified participants.

How do I join the solid tumors clinical trial in San Antonio?

To join this clinical trial in San Antonio, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this San Antonio clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Solid Tumors Clinical Trial in San Antonio, TX

About This Solid Tumors Study in San Antonio

This study is a Phase 1/2, first-in-human, open-label, clinical trial to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of ENV-501 in patients with advanced-stage, relapsed and/or refractory human epidermal growth factor receptor 3 (HER3)-expressing solid tumors. The study consists of 2 phases: a dose escalation phase (Phase 1) and a dose expansion phase (Phase 2). The primary objectives of Phase 1 are to characterize the overall safety and tolerability profile of in

Sponsor: Endeavor Biomedicines, Inc.

Who Can Participate

Inclusion Criteria

Body weight ≥ 40 kg.

Willing and able to provide signed written informed consent before any study-related screening procedures are performed.

Patients with histologically or cytologically confirmed diagnosis of advanced-stage or metastatic HER3+ solid tumors that are relapsed or refractory to or ineligible for standard therapy, or for whom no standard therapy is available; or the patient has documented their refusal of standard of care therapies. These include the following:

Unresectable or metastatic cutaneous melanoma (HER3+)

Locally advanced or metastatic mutated EGFR (mEGFR) NSCLC (HER3+)

Unresectable, locally advanced or metastatic breast cancer

Relapsed or refractory solid tumors, with documented HER3+ expression such as Pancreatic Ductal Adenocarcinoma (PDAC) and gastric cancers, may be allowed in the protocol following sponsor approval on a case-by -case basis.

If molecular pathology report to confirm HER3+ status is not available, willingness to undergo fresh tumor biopsy for retrospective assessment of HER3+ status following enrollment..

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.

Contraceptive requirements:

Women of childbearing potential (WOCBP) must use contraception from at least 28 days prior to study start, during the study, and for at least 6 months after the last dose of study drug.

Males who are sexually active with partner(s) who are WOCBP must agree to use a male condom with spermicide beginning at study start, during the study and for at least 6 months after the last dose of study drug.

Females must:

Agree to not donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 6 months after the last dose of study drug.

Agree to not breastfeed and do not plan to become pregnant during the study and for at least 6 months after the last dose of study drug.

Males must:

Agree to not donate sperm beginning at study start, during the study, and for at least 6 months after the last dose of study drug.

Agree to not plan to father a child beginning at study start, during the study, and for at least 6 months after last dose of study drug.

Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria

Any of the following treatment interventions within the specified time frame prior to study drug administration at study start:

Any anti-tumor-directed drug therapy within 21 days or 5 times the elimination half-life (whichever is shorter).

Treatment with investigational drugs within 21 days.

Major surgery within 21 days.

Radiation therapy ≤4 weeks or radiotherapy that included \>30% of the bone marrow.

Autologous or allogeneic stem cell transplantation or allogeneic tissue/organ transplant within 3 months.

CYP3A4 strong inhibitor (including any prescription or non-prescription drugs or herbal supplements) ≤4 half-lives.

CYP3A4 strong inducer ≤4 half-lives.

OATP1B inhibitor (including any prescription or non-prescription drugs or herbal supplements) ≤4 half-lives.

Prior treatment with a HER3-targeted ADC or any exatecan- or exatecan-derivative-conjugated ADC inhibitor as last line of therapy.

Prior treatment with a topoisomerase I inhibitor as last line of therapy.

Primary immune deficiency (e.g. congenital syndromes).

Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment within 2 weeks prior to study start.

Known/suspected hypersensitivity against ENV-501, human or humanized immunoglobulin Gs (IgGs), or their ingredients.

History of noninfectious or drug-induced pneumonitis or interstitial lung disease (ILD).

Known seropositivity (except after vaccination or confirmed cure for hepatitis) for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).

Leptomeningeal disease, symptomatic or uncontrolled (active) brain metastasis (note: brain metastases not requiring steroids or anti-epileptic therapy are allowed if stable for ≥4 weeks prior to study start and patient is neurologically stable).

Pregnant or WOCBP who have a positive b-human chorionic gonadotropin (HCG) test result at Screening or within 7 days prior to study start.

Patients with second malignancies that are active (uncontrolled, metastatic) or requiring therapy.

Patient who is an immediate family member (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study site or the Sponsor.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in San Antonio?

Yes, this clinical trial (NCT06956690) has an active research site in San Antonio, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Solid Tumors Treatment Options in San Antonio, TX

If you're searching for solid tumors treatment options in San Antonio, TX, this clinical trial (NCT06956690) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our San Antonio research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced solid tumors specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all solid tumors clinical trials near you to find additional studies recruiting in your area.

Solid Tumors Clinical Trial in San Antonio, TX

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