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New treatment option for Advanced Solid Tumors With MAPK Pathway Mutations
Official title A Phase 1/2 Study of D3S-002 as Monotherapy or Combination Therapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations
ClinicalTrials.gov ID: NCT05886920
What this study is testing
What is D3S-002?
D3S-002 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for advanced solid tumors with mapk pathway mutations.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Part 1: people must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor with evidence of progressive disease.
- Part 2: people must have a histologically or cytologically confirmed metastatic or locally advanced non-small cell lung cancer with evidence of PD.
- people with non-small cell lung cancer (NSCLC) should have no known epidermal growth factor receptor (EGFR) mutations, ALK/ROS1/RET rearrangements...
- Part1: people must have documented mitogen-activated protein kinase (MAPK) pathway mutation(s) within the last 5 years identified by a local test on...
- Part 2: Subject must have documented Kirsten rat sarcoma viral oncogene (KRAS) p. glycine 12 to cysteine (p.G12C) mutation identified within the last...
You likely can't join if
- Subject has any prior treatment with other treatments without adequate washout periods as defined in the protocol.
- Part 2: people 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...
- Part 1: Uncontrolled or untreated brain metastasis.
- Part 2: Asymptomatic and stable brain metastases people will be eligible for enrollment per the following criteria.
- Treated or untreated brain metastases
See the full eligibility criteria
- Part 1: people must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor with evidence of progressive disease.
- Part 2: people must have a histologically or cytologically confirmed metastatic or locally advanced non-small cell lung cancer with evidence of PD.
- people 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...
- Part1: people 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...
- 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, people should have no known second KRAS mutations (including G12A, G12V, G12R, G13C, G12D, G12S, H95...
- Part 1: people 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:
- people 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, people, who...
- Part 2: people must have measurable disease per RECIST v1.1.
- Part 2: people 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: people 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.
- people must comply with all reproductive and contraceptive requirements outlined in the protocol.
- Subject has any prior treatment with other treatments without adequate washout periods as defined in the protocol.
- Part 2: people 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...
- Part 1: Uncontrolled or untreated brain metastasis.
- Part 2: Asymptomatic and stable brain metastases people 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
The study team makes the final eligibility decision.
Where it's taking place
- Detroit, Michigan, United States
- New York, New York, United States
- Nashville, Tennessee, United States
- Blacktown, New South Wales, Australia
- Macquarie Park, New South Wales, Australia
- Bedford Park, South Australia, Australia
- Nedlands, Western Australia, Australia
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Harbin, Heilong Jiang, China
- Wuhan, Hubei, China
- Shanghai, Shanghai Municipality, China
- Hangzhou, Zhejiang, China
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Detroit, Michigan, United States; New York, New York, United States; Nashville, Tennessee, United States; Blacktown, New South Wales, Australia; Macquarie Park, New South Wales, Australia; Bedford Park, South Australia, Australia and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.