TY-2136b for Solid Tumors

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: TYK Medicines, Inc

Must not be taking: Immunosuppressants, Anti-arrhythmics, PPIs, others

Disqualifiers: Symptomatic CNS metastases, Cardiovascular disease, Active infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

282 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the safety and tolerability of a new treatment called TY-2136b for people with advanced solid tumors. Researchers will first test different doses to determine the safest and most effective amount, followed by further testing in specific groups. The trial seeks participants with advanced or metastatic solid tumors that have certain gene changes, such as ALK, ROS1, or NTRK alterations, especially if standard treatments have not been successful. Participants should be able to swallow tablets and have at least one measurable tumor. As a Phase 1 trial, this research focuses on understanding how TY-2136b works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as strong inhibitors or inducers of specific enzymes (CYP3A, P-glycoprotein) and proton pump inhibitors, before starting the study drug. If you're on these medications, you may need to stop them 2 weeks or a few days before the trial, depending on the type.

Is there any evidence suggesting that TY-2136b is likely to be safe for humans?

Research shows that TY-2136b is undergoing tests to understand its safety and how the body processes it. Earlier patients who took different doses of TY-2136b helped researchers determine how well the treatment was tolerated. This process helps identify the right dose that is both effective and safe for future patients.

Since this study is in its early stages, it primarily focuses on safety. Researchers closely monitor how patients react to the treatment and any side effects they might experience. This step is crucial to ensure that TY-2136b is safe for more people in later trials.

There is no specific data on side effects or adverse reactions yet. However, early-stage trials are designed to carefully monitor and manage any potential risks. If TY-2136b proves to be well-tolerated, it will proceed to further testing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about TY-2136b because it offers a new approach for treating solid tumors. Unlike traditional treatments like chemotherapy, which target all rapidly dividing cells, TY-2136b is designed to be more selective, potentially targeting tumor cells more precisely with an innovative mechanism of action. This targeted approach could mean fewer side effects and a better quality of life for patients. Additionally, TY-2136b is administered orally, which is more convenient compared to many existing treatments that require intravenous infusions.

What evidence suggests that TY-2136b might be an effective treatment for solid tumors?

Research shows that TY-2136b blocks signals that help cancer cells grow and survive. This method has shown promise in targeting specific genetic changes in cancer, such as ALK and ROS1. Some studies found TY-2136b to be more effective than other treatments, like selitrectinib. Early data suggest patients might see benefits in about 1.8 months, with a typical time of 30.8 months before the cancer worsens. These results indicate potential for TY-2136b in treating solid tumors, though more research is needed to confirm its effectiveness. Participants in this trial will receive TY-2136b either in the escalation stage to determine the maximum tolerated dose or in the expansion stage across four distinct cohorts. ^{4 5 6 7 8}

Who Is on the Research Team?

TYK Medicines, Inc

Principal Investigator

TYK Medicines, Inc

Are You a Good Fit for This Trial?

Adults with advanced solid tumors and specific genetic changes (ALK, ROS1, NTRK1-3) who've tried standard treatments without success or can't tolerate them. They must be able to swallow tablets, have a life expectancy of at least 3 months, use effective contraception if of childbearing potential, and not have symptomatic brain metastases or certain lung diseases.

Inclusion Criteria

At least 1 measurable target lesion according to Response Evaluation Criteria in Solid Tumor Version 1.1 (RECIST v1.1)

I have had chemotherapy or immunotherapy for cancer before.

I am willing and able to sign a consent form approved by an ethics committee.

Exclusion Criteria

Concurrent participation in another therapeutic clinical trial, unless in follow-up period of a previous interventional clinical trial

I haven't had serious heart problems in the last 6 months.

I haven't had major surgery in the last 4 weeks or radiation therapy in the last 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Multiple doses of TY-2136b are administered to find the maximum tolerated dose

28 days

Cycle 1 Day 1 and Cycle 1 Day 21 (at pre-dose, 0.5, 1, 2, 4, 6, 24 hours post-dose)

Dose Expansion

4 distinct expansion cohorts receive TY-2136b to evaluate safety and efficacy

Up to 30 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TY-2136b

Trial Overview The trial is testing the safety and ideal dosage of TY-2136b in two stages: dose escalation to find the safe maximum dose and dose expansion to study its effects more broadly. Participants will take TY-2136b to see how it affects their tumors.

How Is the Trial Designed?

Group I: Expansion stage Experimental Treatment 1 Intervention

Expansion stage: 4 distinct expansion cohorts

Group II: Escalation stage Experimental Treatment 1 Intervention

Escalation stage: Multiple doses of TY-2136b for oral administration to find the maximum tolerated dose

Who Is Running the Clinical Trial?

TYK Medicines, Inc

Lead Sponsor

Trials

13

Recruited

2,300+

Published Research Related to This Trial

Targeted and immunological therapies have significantly improved survival rates in patients with solid tumors, demonstrating the effectiveness of treatments that focus on specific genetic and immunological changes in tumors.

Current clinical trials are exploring the optimal timing and sequencing of these therapies, which include various approved agents for cancers like prostate, breast, lung, and melanoma, indicating a shift towards more personalized cancer treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pharmacotherapy of solid tumors. New hopes and frustrations]. Grünwald, V., Rickmann, M.[2021]

Recent advances in antibody-based therapies, such as trastuzumab and bevacizumab, have shown promise in treating various solid tumors, including breast and colorectal cancers, with acceptable safety profiles.

Combining monoclonal antibodies with small-molecule inhibitors may enhance treatment efficacy and specificity, suggesting a potential direction for future cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances relating to the clinical application of naked monoclonal antibodies in solid tumors. Argyriou, AA., Kalofonos, HP.[2021]

Imatinib is an effective tyrosine kinase inhibitor that targets specific pathways involved in cancer, showing significant activity in chronic myeloid leukaemia (CML) and gastrointestinal stromal tumours (GISTs), with response rates over 50% in clinical trials.

In large randomized trials, imatinib demonstrated a higher complete hematological and cytogenetic response rate compared to traditional treatments for CML, and higher doses were associated with improved progression-free survival, highlighting its potential as a targeted cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development and application of imatinib. Jones, RL., Judson, IR.[2019]

Overactivation of the ErbB protein family is linked to various cancers, leading to the development of targeted therapies like EGFR and HER2 inhibitors, which have shown clinical activity in treating non-small cell lung cancer (NSCLC) and breast cancer.

Agents such as afatinib, dacomitinib, and neratinib are currently in advanced clinical trials, with afatinib already approved for EGFR mutation-positive NSCLC, indicating promising efficacy for these targeted treatments in solid tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irreversible multitargeted ErbB family inhibitors for therapy of lung and breast cancer. Subramaniam, D., He, AR., Hwang, J., et al.[2019]

Afatinib is an irreversible blocker of the ErbB family of receptors that has shown strong anti-tumor effects in preclinical studies and clinical efficacy in patients with non-small-cell lung cancer, as well as activity in head and neck squamous cell carcinoma and breast cancer.

The development of afatinib is particularly important as it addresses the growing issue of treatment resistance seen with existing therapies targeting ErbB signaling, offering a potential new option for patients with these cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical and clinical development of afatinib: a focus on breast cancer and squamous cell carcinoma of the head and neck. Harbeck, N., Solca, F., Gauler, TC.[2019]

Gefitinib, a tyrosine kinase inhibitor targeting the epidermal growth factor receptor (EGFR), has shown significant efficacy in treating non-small-cell lung cancer (NSCLC), leading to its FDA approval for this refractory disease.

In combination with standard chemotherapy, gefitinib has demonstrated improved response rates in colorectal cancer (75% vs. 55%) and has a mild toxicity profile, making it a promising addition to cancer treatment regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gefitinib (Iressa, ZD1839) and tyrosine kinase inhibitors: the wave of the future in cancer therapy. Penne, K., Bohlin, C., Schneider, S., et al.[2019]

Gefitinib is an orally active EGFR-tyrosine kinase inhibitor that effectively blocks cancer cell growth by interfering with signaling pathways, and it has been approved for use in several countries since the early 2000s.

Current clinical trials are exploring gefitinib's efficacy across various solid tumors, including non-small-cell lung cancer and breast cancer, both as a standalone treatment and in combination with other therapies, highlighting its potential to improve cancer treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gefitinib: current and future status in cancer therapy. Herbst, RS., Kies, MS.[2018]

ErbB signaling plays a crucial role in the development of many solid cancers, leading to the creation of targeted therapies like monoclonal antibodies (mAbs) and tyrosine kinase inhibitors (TKIs) for treatment.

Despite their effectiveness, both mAbs and TKIs face challenges with cancer resistance, prompting a shift towards combination therapies as a promising strategy for improving cancer treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ErbB antagonists patenting: "playing chess with cancer". Aifa, S., Rebai, A.[2019]

Erlotinib demonstrated a disease control rate of 52.5% in patients with non-small cell lung cancer who previously responded to gefitinib, indicating it can be an effective treatment option after gefitinib failure.

There was no significant difference in efficacy between patients who received erlotinib immediately after gefitinib failure and those who had chemotherapy in between, suggesting flexibility in treatment sequencing for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy of erlotinib after the failure of gefitinib in patients with metastasis of non-small cell lung cancer with unknown EGFR mutation status]. Wang, Y., Li, JL., Wang, ZP., et al.[2018]

Citations

1. theros1ders.org theros1ders.org/drugs-to-treat-ros1-cancer

Treating Stage 4 ROS1 (for HCPs) Learn more about treating ROS1+ Cancer, a guide specifically designed for healthcare professionals.

2. withpower.com withpower.com/trial/phase-1-neoplasms-2-2023-349eb

TY-2136b for Solid Tumors These drugs work by blocking signals that help cancer cells grow and survive, suggesting that similar mechanisms might support the effectiveness of TY-2136b.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1040842823003220

Oncogenic fusions: Targeting NTRK ... TY-2136b and repotrectinib were more effective compared to selitrectinib. A current phase 1/2 clinical trial evaluating TY-2136b in patients with ALK, ROS ...

4. tykmedicines.com tykmedicines.com/en/wp-content/uploads/2025/05/BD-research-report-.pdf

TYK Medicines trials of TY-2136b for the treatment of solid tumors from the FDA in November 2021. ... Phase I and Phase II clinical trials of TY-1091 in solid ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11475940/

Tissue-Agnostic Targeting of Neurotrophic Tyrosine Receptor ... The median time to a response was 1.8 months, and the median progression-free survival time was 30.8 months [35]. In patients for whom ...

6. ctv.veeva.com ctv.veeva.com/study/a-study-of-ty-2136b-in-patients-with-advanced-solid-tumors-harboring-alk-ros1-or-ntrk1-3-alteration

A Study of TY-2136b in Patients With Advanced Solid Tumors ... The primary objective of this study is to evaluate the safety and tolerability of TY-2136b and to determine the recommended phase 2 dose (RP2D), ...

7. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/400055

A Study of TY-2136b in Patients With Advanced Solid ... The primary objective of this study is to evaluate the safety and tolerability of TY ... data collected during the dose escalation portion ...

8. clin.larvol.com clin.larvol.com/trial/NCT05769075

A Study of TY-2136b in Patients With Advanced Solid ... ... safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamic (PD) data collected during the dose escalation portion of the study. Within 28 ...