Is NCT05886920 recruiting in Detroit, MI?

Yes, NCT05886920 is currently recruiting participants at its Detroit, MI location. This advanced solid tumors with mapk pathway mutations clinical trial is actively enrolling qualified participants.

Is participation in this Detroit 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.

Advanced Solid Tumors With MAPK Pathway Mutations Clinical Trial in Detroit, MI

Q: How do I join the advanced solid tumors with mapk pathway mutations clinical trial in Detroit?

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

About This Advanced Solid Tumors With MAPK Pathway Mutations Study in Detroit

This first-in-human (FIH) study aims to assess the safety, tolerability, pharmacokinetics, and recommended phase 2 dose (RP2D) of D3S-002 given orally daily for 21-day cycles in adult subjects with advanced solid tumors with mitogen-activated protein kinase (MAPK) pathway mutations.

Sponsor: D3 Bio (Wuxi) Co., Ltd

Who Can Participate

Inclusion Criteria

Part 1: Subjects must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor with evidence of progressive disease.

Part 2: Subjects must have a histologically or cytologically confirmed metastatic or locally advanced non-small cell lung cancer with evidence of PD.

Subjects with non-small cell lung cancer (NSCLC) should have no known epidermal growth factor receptor (EGFR) mutations, ALK/ROS1/RET rearrangements, NTRK1/2/3 gene fusions, v-Raf murine sarcoma viral oncogene homolog B (BRAF) V600E mutations, or MET exon 14 skipping mutations. Note: EGFR mutations include but are not limited to EGFR Exon19 Deletions, Exon21 p.L858R, Exon21 p.L861Q, Exon18 p.G719X, Exon20 p.S768I, Exon20 Insertions, Exon20 p.T790M. If other EGFR mutations are present, the Investigator should have a consultation with the sponsor's Medical Monitor before making the enrollment decision.

Part1: Subjects must have documented mitogen-activated protein kinase (MAPK) pathway mutation(s) within the last 5 years identified by a local test on tumor tissue or blood (eg, rat sarcoma (RAS), rapidly accelerated fibrosarcoma (RAF), and MAPK kinase (MAPKK) mutations).

Part 2: Subject must have documented Kirsten rat sarcoma viral oncogene (KRAS) p. glycine 12 to cysteine (p.G12C) mutation identified within the last 5 years by a local test on tumor tissue or blood. Note: • All the local tests should clearly distinguish KRAS p.G12C from all other KRAS p.G12x variants. If not specified, subjects should have no known second KRAS mutations (including G12A, G12V, G12R, G13C, G12D, G12S, H95, Y96, Q61, and R68).

Part 1: Subjects must be refractory to or intolerable with standard treatment, or have no available standard of care (SOC).

Part 2: Subject must have received at least 1 line of prior standard of care systemic therapy for locally advanced and unresectable or metastatic disease, including KRAS p.G12C inhibitor. Note:

Subjects should only have received 1 type of prior KRAS p.G12Ci treatment (including all types of KRAS p.G12C inhibitor which are either under investigation or in market, except D3S-001).

During the prior KRAS p.G12C treatment, subject has achieved best response of partial or complete response regardless of KRAS p.G12Ci treatment duration, or stable disease for at least 6 months. However, subjects, who have stopped KRAS p.G12Ci therapy earlier than 6 months due to safety/tolerability reasons only, would be allowed. In such a situation, the Investigator should have a consultation with the Sponsor Medical Monitor before making the enrollment decision.

Part 2: Subjects must have measurable disease per RECIST v1.1.

Part 2: Subjects must agree to provide archival tumor tissue, if available, for genetic analysis. If archival tumor tissue is not available, or of insufficient quantity, an optional fresh biopsy is highly recommended.

Part 2: Subjects must agree to provide blood samples for genetic analysis (Table 2 schedule of activities for Part 2).

Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

Subject must have adequate organ and marrow function within the screening period.

Subjects must comply with all reproductive and contraceptive requirements outlined in the protocol.

Exclusion Criteria

Subject has any prior treatment with other treatments without adequate washout periods as defined in the protocol.

Part 2: subjects with mixed small-cell lung cancer, or large cell neuroendocrine histology, or sarcomatoid carcinoma.

Subject has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, uncontrolled or significant cardiovascular disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring AEs, or compromise the ability of the subject to give written informed consent.

Part 1: Uncontrolled or untreated brain metastasis.

Part 2: Asymptomatic and stable brain metastases subjects will be eligible for enrollment per the following criteria.

Treated or untreated brain metastases

Neurologically asymptomatic

Stable and not requiring steroids more than 10 mg/day of prednisone or equivalent for at least 4 weeks prior to the first dose of study medication.

Subject has unresolved treatment-related toxicities from previous anticancer therapy of NCI CTCAE Grade ≥2 (with exception of vitiligo or alopecia).

Subject has active gastrointestinal disease or other that could interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy.

Any concurrent chemotherapy, immunotherapy, targeted therapy, cell therapy, biologic or hormonal therapy and any medical devices for cancer treatment. NOTE: Other protocol inclusion/exclusion criteria may apply

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 Detroit?

Yes, this clinical trial (NCT05886920) has an active research site in Detroit, MI 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.

Advanced Solid Tumors With MAPK Pathway Mutations Treatment Options in Detroit, MI

If you're searching for advanced solid tumors with mapk pathway mutations treatment options in Detroit, MI, this clinical trial (NCT05886920) 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 Detroit research site is actively enrolling participants for this clinical trial. You'll receive care from experienced advanced solid tumors with mapk pathway mutations 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 advanced solid tumors with mapk pathway mutations clinical trials near you to find additional studies recruiting in your area.

Advanced Solid Tumors With MAPK Pathway Mutations Clinical Trial in Detroit, MI

Expert Care in Detroit

IRB Approved

No-Cost Care

Apply for This Detroit Location

Why Participate?

Simple Process