Baltimore, MDNCT06934538Now EnrollingIRB Ready

Unresectable Metastatic Colorectal Cancer Clinical Trial in Baltimore, MD

Access cutting-edge unresectable metastatic colorectal cancer treatment through this clinical trial at a research site in Baltimore. Study-provided care at no cost to qualified participants.

Sponsored by Brenus Pharma

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Expert Care in Baltimore

Access unresectable metastatic colorectal cancer specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related unresectable metastatic colorectal cancer treatment provided free

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Check if you qualify for this unresectable metastatic colorectal cancer clinical trial in Baltimore, MD

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Why Participate?

  • No-Cost Study Care

  • Local to Baltimore

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Baltimore site if eligible
  4. 4Begin participation

About This Unresectable Metastatic Colorectal Cancer Study in Baltimore

This is a phase I/IIA, first-in-human (FIH), two-part, open-label, multicenter study to characterize the safety, tolerability profile, and clinical efficacy of STC-1010 associated with GM-CSF and cyclophosphamide immunostimulant (IS) regimen administered with standard of care (SOC) therapy (mFOLFOX6 with or without bevacizumab) to participants with unresectable locally advanced (stage IIIC, T4b) or unresectable metastatic (stage IV) colorectal cancer (CRC). The trial will be conducted in two parts: * A Phase I consisting of a dose escalation part and small expansion part to determine the maximum tolerated dose (MTD), recommended Phase II dose (RP2D) and safety profile of the STC-1010 + IS regimen administered with SOC therapy. Approximately 21 to 33 participants will be included in this phase in Europe. * A Phase IIA consisting of the expansion stage of the study which will further evaluate the clinical efficacy and safety of STC-1010 on a larger number of participants treated at the identified RP2D. Approximately 57 to 60 participants will be enrolled in total in 2 different arms. Multi-site recruitment will take place in Europe and in the US.

Sponsor: Brenus Pharma

Who Can Participate

Inclusion Criteria

Male or female aged 18-75 years
Histologically confirmed diagnosis of unresectable locally advanced (stage IIIC, T4b) or unresectable metastatic (stage IV) (R0) adenocarcinoma of the colon or rectum
Adjuvant fluoropyrimidine monotherapy or oxaliplatin-based chemotherapy allowed if more than 6 months have elapsed between the end of adjuvant treatment and first relapse
Determination of KRAS and BRAF mutation status
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Must agree to have biopsy at screening and on-treatment, only if not representing an unacceptable clinical risk and/or if technically feasible as judged by the Investigator in discussion with the interventional radiologist or endoscopist
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1. Participants \>70 years must have a PS= 0.
Life expectancy \> 3 months as assessed by the investigator
Effective contraceptive measures implemented

Exclusion Criteria

Patients with symptomatic ascites or pleural effusion
Dihydropyrimidine dehydrogenase (DPD) deficiency
Resectable tumor with curative intent or patient considered for a curative strategy by intensifying chemotherapy to induce resectability
Prior chemotherapy for metastatic disease
Prior immunotherapy for advanced/metastatic disease (except for Arm 2A-2)
Prior therapy with an investigational agent
BRAF mutation
Active auto-immune diseases such as rheumatoid arthritis, lupus, Crohn's disease, ulcerative colitis
Medical conditions requiring immunosuppressive therapy
Major surgery \<4 weeks prior to first administration of STC-1010
Radiotherapy \< 4 weeks prior to first administration of STC-1010 or \< 2 weeks in case of palliative radiotherapy
Prior stem cell or solid organ transplantation
Dementia or altered mental status or subject of a legal protection measure that would prohibit informed consent
Active drug or alcohol abuse as assessed by the Investigator
Participant deprived of their liberty by a judicial or administrative decision, undergoing psychiatric care and admitted to a health or social establishment for purposes other than research.

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 Baltimore?

Yes, this clinical trial (NCT06934538) has an active research site in Baltimore, MD 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.

Unresectable Metastatic Colorectal Cancer Treatment Options in Baltimore, MD

If you're searching for unresectable metastatic colorectal cancer treatment options in Baltimore, MD, this clinical trial (NCT06934538) 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 Baltimore research site is actively enrolling participants for this clinical trial. You'll receive care from experienced unresectable metastatic colorectal cancer 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 unresectable metastatic colorectal cancer clinical trials near you to find additional studies recruiting in your area.

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