MYTX-011 for Lung Cancer

Recruiting at 86 trial locations

Overseen By William T Downing

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Mythic Therapeutics

Disqualifiers: CNS metastases, Interstitial lung disease, Active infection, others

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

Compensation: Varies

Number of Visits: Unknown

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called MYTX-011 for individuals with advanced lung cancer, specifically non-small cell lung cancer (NSCLC). The trial aims to determine the safety and initial effectiveness of this medication, which combines an antibody targeting a specific protein with a powerful anti-cancer drug. Participants should have advanced lung cancer that has persisted despite previous standard treatments. The study includes multiple groups to test different doses and specific cancer profiles, such as those with certain genetic traits or protein expressions.

As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that MYTX-011 is likely to be safe for humans?

Research has shown that MYTX-011, a new drug tested for lung cancer, demonstrated promising safety results in earlier studies. Patients who received doses of 4.0 mg/kg or higher, considered effective, provided researchers with important safety information. These studies examined patient tolerance and monitored for side effects.

The drug is an antibody-drug conjugate (ADC) that specifically targets cancer cells, helping to protect healthy cells and often resulting in fewer side effects. Although detailed safety information is still being collected, MYTX-011's progression to clinical trials indicates promising initial safety results.

As MYTX-011 remains in early testing stages, researchers continue to learn about its safety. Current evidence suggests it might be well-tolerated at certain doses. As with any trial, discussing potential risks and benefits with a healthcare provider is important before deciding to participate. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about MYTX-011 for lung cancer because it offers a new approach compared to standard treatments like chemotherapy and targeted therapies. While most current treatments either attack fast-dividing cells or inhibit specific cancer growth factors, MYTX-011 has a unique mechanism of action, though the specifics are still being investigated. This experimental drug's ability to target lung cancer differently could lead to more effective treatment options and potentially fewer side effects. As researchers explore various dosages in clinical trials, they hope to unlock more efficient and precise ways to combat lung cancer.

What evidence suggests that MYTX-011 might be an effective treatment for lung cancer?

Research has shown that MYTX-011, the investigational treatment in this trial, has promising effects against tumors in early studies. In tests with mice that had non-small cell lung cancer (NSCLC), MYTX-011 proved at least three times more effective than a similar treatment. Early results from human studies demonstrated strong tumor responses and lasting effects in lung cancer patients. Additionally, MYTX-011 was well-tolerated, causing fewer side effects than other similar treatments. These findings suggest MYTX-011 could be a powerful option for people with advanced lung cancer. ^{3 5 6 7 8}

Who Is on the Research Team?

Ting Wu, MD MSc

Principal Investigator

Mythic Therapeutics

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have tried standard treatments. They must have measurable tumors, acceptable organ function, and agree to use birth control. People can't join if they've had recent major surgery, untreated brain metastases, significant liver disease, active infections needing IV treatment, or certain lung conditions.

Inclusion Criteria

My advanced lung cancer has been confirmed and I've tried all standard treatments.

My cancer does not have treatable EGFR mutations but may have other mutations.

My squamous NSCLC is advanced, recurrent, or metastatic with high cMET levels.

Exclusion Criteria

I have brain metastases that haven't been treated.

My neuropathy is mild or I don't have it.

I have not had major surgery in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Part 1 assesses the safety and tolerability of MYTX-011 and identifies the dose to be studied in Part 2

Up to 21 days

Multiple visits (in-person)

Dose Expansion

Part 2 includes subjects with NSCLC with cMET overexpression or MET amplification/exon 14 skipping mutations

24 months

Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• MYTX-011

Trial Overview The study tests MYTX-011, an antibody-drug conjugate targeting cMET in NSCLC. It's given to see how safe it is and how well it works at different stages of the disease based on prior treatments and tumor characteristics like cMET expression levels.

How Is the Trial Designed?

Group I: Part 2 Cohort F Experimental Treatment 1 Intervention

Part 2 Cohort F patients will receive MYTX-011 at the recommended phase 2 dose.

Group II: Part 2 Cohort E2 Experimental Treatment 1 Intervention

Part 2 Cohort E2 patients will be randomized to two different dose levels of MYTX-011. Doses to be determined after completion of Part 1

Group III: Part 2 Cohort E Experimental Treatment 1 Intervention

Part 2 Cohort E patients will receive MYTX-011 at the recommended phase 2 dose.

Group IV: Part 2 Cohort D Experimental Treatment 1 Intervention

Part 2 Cohort D patients will receive MYTX-011 at the recommended phase 2 dose.

Group V: Part 2 Cohort C Experimental Treatment 1 Intervention

Part 2 Cohort C patients will receive MYTX-011 at the recommended phase 2 dose.

Group VI: Part 2 Cohort B2 Experimental Treatment 1 Intervention

Part 2 Cohort B2 patients will be randomized to two different dose levels of MYTX-011. Doses to be determined after completion of Part 1

Group VII: Part 2 Cohort B Experimental Treatment 1 Intervention

Part 2 Cohort B patients will receive MYTX-011 at the recommended phase 2 dose.

Group VIII: Part 2 Cohort A Experimental Treatment 1 Intervention

Part 2 Cohort A patients will be randomized to two different dose levels of MYTX-011. Doses to be determined after completion of Part 1.

Group IX: Part 1 Dose Escalation Experimental Treatment 1 Intervention

Part 1 patients will receive MYTX-011.

Who Is Running the Clinical Trial?

Mythic Therapeutics

Lead Sponsor

Trials

1

Recruited

250+

Published Research Related to This Trial

In a study of 191 patients with non-small cell lung cancer (NSCLC) treated with PD-1/PD-L1 inhibitors, those who experienced immune-related adverse events (irAEs) had significantly better treatment outcomes, with an objective response rate of 42.0% compared to 25.8% in those without irAEs.

The presence of irAEs was associated with improved progression-free survival, suggesting that these adverse events may indicate a more effective immune response to the treatment, although they did not correlate with overall survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune-Related Adverse Events and Their Association With the Effectiveness of PD-1/PD-L1 Inhibitors in Non-Small Cell Lung Cancer: A Real-World Study From China. Chen, X., Nie, J., Dai, L., et al.[2022]

In a meta-analysis of 4413 patients from 8 randomized controlled trials, PD-1/PD-L1 inhibitors showed a significantly lower risk of all-grade adverse events (66.20% vs. 86.08%) and high-grade adverse events (14.26% vs. 43.53%) compared to chemotherapy, indicating a better safety profile.

While PD-1/PD-L1 inhibitors are generally safer, they are associated with a unique set of immune-related adverse events (irAEs) that can be severe, such as pneumonitis and thyroid dysfunction, which clinicians need to monitor closely to manage patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of PD-1/PD-L1 inhibitors in the treatment of non-small cell lung cancer: a meta-analysis of randomized controlled trials. Luo, W., Wang, Z., Tian, P., et al.[2021]

In a study of 96 lung cancer patients who received thoracic radiotherapy (TRT) after PD-(L)1 inhibitor treatment, nearly 49% developed symptomatic treatment-related pneumonitis, indicating a significant safety concern with this treatment sequence.

Independent risk factors for developing pneumonitis included pulmonary emphysema and lung V20 exposure, highlighting the need for careful patient selection and monitoring when using TRT after PD-(L)1 inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of thoracic radiotherapy after PD-(L)1 inhibitor treatment in patients with lung cancer. Chen, Y., Liu, X., Huang, Z., et al.[2022]

In a phase II study involving 14 patients with advanced non-small cell lung cancer (NSCLC) who had already undergone multiple treatments, the combination of S-1 with either irinotecan or docetaxel did not demonstrate significant efficacy as a salvage treatment.

The median survival time for participants was only 5.6 months, and the study was halted early due to a lack of responses, indicating that this treatment approach is not recommended for further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II Study of S-1 Plus Either Irinotecan or Docetaxel for Non-small Cell Lung Cancer Patients Treated with More Than Three Lines of Treatment. Kim, DY., Lee, DH., Jang, SJ., et al.[2021]

In a randomized phase II study of 62 patients with advanced non-small cell lung cancer, the combination of larotaxel and cisplatin showed a higher objective response rate and longer progression-free survival compared to larotaxel and gemcitabine.

Both treatment combinations were manageable in terms of safety, but the larotaxel-cisplatin group had better efficacy outcomes, suggesting it may be the more promising option for first-line treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized multicenter phase II study of larotaxel (XRP9881) in combination with cisplatin or gemcitabine as first-line chemotherapy in nonirradiable stage IIIB or stage IV non-small cell lung cancer. Zatloukal, P., Gervais, R., Vansteenkiste, J., et al.[2022]

Immune checkpoint antibodies targeting the PD-1/PD-L1 pathway have shown significant antitumor activity and have been approved for use as single-agent therapies in metastatic malignant melanoma and nonsmall-cell lung cancer.

Understanding the toxicities associated with PD-1/PD-L1 blockade and having effective management strategies is crucial for maximizing both the safety and efficacy of these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicities of the anti-PD-1 and anti-PD-L1 immune checkpoint antibodies. Naidoo, J., Page, DB., Li, BT., et al.[2023]

In a study of 66 patients with operable stage III non-small cell lung cancer (NSCLC), the combination of Camrelizumab with Docetaxel and Cisplatin showed good overall safety, with most adverse events (AEs) being mild (grade 1-2) and only 9.1% being severe (grade 3-4).

The supervision of adverse events during neoadjuvant therapy not only helped in managing complications but also led to an improvement in patients' quality of life, indicating that careful monitoring can enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Role of Adverse Events Supervision in Clinical Trials in Neoadjuvant Treatment of Operable Stage III NSCLC]. Zhang, Y., Zhou, S., Tao, W., et al.[2023]

In a study of 40 patients with completely resected stage II and IIIA non-small cell lung cancer, combining concurrent carboplatin/paclitaxel chemotherapy with thoracic radiotherapy (TRT) showed promising outcomes, with 2-year and 5-year overall survival rates of 92% and 88%, respectively.

The treatment was generally well-tolerated, with 92% of patients receiving the planned TRT doses, although some experienced significant side effects, including grade 3 esophagitis and pneumonitis, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II study of concurrent carboplatin and paclitaxel and thoracic radiotherapy for completely resected stage II and IIIA non-small cell lung cancer. Feigenberg, SJ., Hanlon, AL., Langer, C., et al.[2015]

The maximum tolerated dose (MTD) for the carboplatin and paclitaxel combination was established at 235 mg/m2 and 375 mg/m2, respectively, showing a good safety profile with minimal neutropenia and no thrombocytopenia in 50 patients with advanced non-small cell lung cancer.

The treatment resulted in an overall response rate of 38%, with a median overall survival time of 51.81 weeks and a 1-year survival rate of 49%, indicating that this combination therapy is both effective and well tolerated in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/II dose finding study of paclitaxel and carboplatin in advanced non-small cell lung cancer. Scagliotti, GV., Crinó, L., Pozzi, E., et al.[2019]

In a phase II study involving 20 patients with locally advanced non-small cell lung cancer, the combination of weekly paclitaxel and cisplatin with thoracic radiotherapy showed a 43.8% objective response rate, indicating some efficacy in treating this aggressive cancer.

However, the treatment was associated with a high incidence of severe toxicities (75% of patients experienced grade 3/4 side effects), leading to early discontinuation of treatment for some patients and ultimately prompting the study's closure due to safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II study of weekly paclitaxel, cisplatin and concurrent radiation therapy for locally-advanced unresectable non-small cell lung cancer: early closure due to lack of efficacy. Park, SH., Kim, MK., Kyung, SY., et al.[2021]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.8613

MYTX-011, a cMET-targeting antibody-drug conjugate ... Conclusions: MYTX-011 is well tolerated with low rates and severity of AEs commonly associated with cytotoxic and cMET-targeting agents.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05652868

Clinical Study of Antibody-Drug Conjugate MYTX-011 in ... This is a Phase I open label multi-center study to evaluate the safety, tolerability, pharmacokinetics and preliminary effectiveness of the investigational ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38684230/

MYTX-011: a pH-dependent anti-cMET antibody-drug ... A single dose of MYTX-011 showed at least three-fold higher efficacy than a benchmark ADC in mouse xenograft models of NSCLC ranging from low to ...

4. mythictx.com mythictx.com/wp-content/uploads/2025/05/2025-ASCO-Poster-final.pdf

2025-ASCO-Poster-final.pdf As of 24 April 2025, 92 patients received ≥1 dose of MYTX-011 in Part 1 from 1.0 to 8.3 mg/kg Q3W. • 66 patients received doses of 4.0 mg/kg Q3W or higher ...

5. firstwordpharma.com firstwordpharma.com/story/5967756

ADC, MYTX-011, in Non-Small Cell Lung Cancer at the ... “The early data from the MYTX-011 study, showing compelling anti-tumor activity and durable responses in patients with lung cancer, together ...

6. aacrjournals.org aacrjournals.org/mct/article/23/9/1282/747349/MYTX-011-A-pH-Dependent-Anti-c-MET-Antibody-Drug

MYTX-011: A pH-Dependent Anti–c-MET Antibody–Drug ... MYTX-011 drove fourfold higher net internalization than a non–pH-engineered parent ADC in non–small cell lung cancer (NSCLC) cells and showed ...

7. fredhutch.org fredhutch.org/en/research/clinical-trials/trial-details.fh_trial_id_15154.clinical-study-of-antibody-drug-conjugate-mytx-011-in-subjects-with-non-small-cell-lung-cancer.html

Clinical Study of Antibody-Drug Conjugate MYTX-011 in ... This is a Phase I open label multi-center study to evaluate the safety, tolerability, pharmacokinetics and preliminary effectiveness of the ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05652868

Clinical Study of Antibody-Drug Conjugate MYTX-011 in ... This is a Phase I open label multi-center study to evaluate the safety, tolerability, pharmacokinetics and preliminary effectiveness of the investigational ...