Recruiting
Phase 1

MX006

Sponsor:

Myricx Pharma Limited

Code:

NCT07807241

Conditions

Advanced and/or Metastatic Solid Tumors Known to Express B7-H3

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MX006

Study Details

Brief summary:

This is a Phase 1a/1b, multicenter, open-label, first-in-human (FIH) study with MX006 treatment in patients with selected tumor types known to express B7-H3. The study will include 2 parts:

  • Dose-escalation (Part A)
  • Dose-expansion (Part B) A maximum of 120 patients may be enrolled in this study. The primary objective of the dose escalation (PART A) is to evaluate the safety and tolerability of MX006 and determine the maximum-tolerated dose (MTD) and the recommended doses for expansion (RDE) in patients with selected solid tumors; whereas the primary objective of the dose expansion (PART B) is to evaluate the safety and tolerability of MX006 at the dose level (s) recommended in Part A.

Conditions

Advanced and/or Metastatic Solid Tumors Known to Express B7-H3

Study ID

NCT07807241

Start date

Jul 20, 2026

Status verified date

Sep, 2026

Completion date

Jul, 2030

Anticipated

Primary completion date

Jul, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male and female patients aged 18 years-or older at the time of signature of the informed consent form.
  • Patients with advanced/metastatic cancer, with measurable disease as determined by RECIST v1.1 or the Prostate Cancer Clinical Trials Working Group 3 (for mCRPC only) as per Investigator discretion. Note: Patients with mCRPC can be enrolled without measurable disease but must have a minimum of 2 bone lesions and increased PSA.
  • Histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors in patients with relapsed or refractory solid tumors known to express B7-H3 who have failed available standard therapy or who are not candidates for standard therapy.
  • Has adequate bone marrow and organ function within 7 days before the start of study
  • Has an adequate treatment washout period prior to start of study treatment, defined as:
  • Major surgery: ≥4 weeks (or 2 weeks for low-invasive cases \[e.g., colostomy\]). Note: major surgery is defined for example as a surgical procedure that is complex, invasive (e.g., enters a body cavity), is associated with higher risk of complications, and may require general anesthesia and hospitalization.
  • Radiation therapy: ≥4 weeks (if palliative single site stereotactic radiation therapy, ≥2 weeks.)

Exclusion Criteria:

  • Prior treatment with an NMT inhibitor or any antibody-drug conjugate (ADC) that delivers an NMTi payload.
  • Has other invasive malignancy within 2 years; prior or concurrent non-invasive malignancies (with the exception of the following: in situ carcinomas of the cervix, non-melanoma skin cancers) and/or patients with localized malignancies that were treated with curative intent (e.g., localized breast cancer) who remain disease-free and are considered low likelihood for recurrence who may be enrolled on a case-by-case basis after discussion with the Medical Monitor).
  • Have clinically significant cardiac disease, known congestive heart failure (New York Heart Association classes II-IV) or a serious cardiac arrhythmia requiring treatment, and/ or a known decreased cardiac ejection fraction of < 45%. A baseline QT interval as corrected by Fridericia's formula (QTcF) > 470 msec, a complete left bundle branch block (defined as a QRS interval ≥ 120 msec in left bundle branch block form) or an incomplete left bundle branch block based on the average of triplicate 12-lead electrocardiogram (ECG) per local read.
  • Received any of the following within the specified time frame prior to administration of study treatment: Any systemic agent from a previous treatment regimen or clinical study including anti-cancer chemotherapy or small molecule ≤14 days or 5 half-lives (whichever is shorter); any biologic or hormonal agent ≤28 days or 5 half-lives (whichever is shorter).
  • Received any of the following within the specified time frame prior to administration of study treatment: Platelet transfusion, red blood cell transfusion and/or granulocyte colony-stimulating factor administration < 1 week prior to screening assessments.

Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A: Dose escalation

Dose-escalation (Part A): Patients with solid tumors known to express B7-H3 will be included in the dose-escalation phase in which the MTD and/or RDE/RDEs of MX006 monotherapy will be determined.

experimental: Part B: Dose-expansion

Dose-expansion (Part B): Part B will commence in patients with selected tumor cohorts after available data is assessed from Part A. For dose expansion patients may be randomized to three dose cohorts.

Interventions

MX006

Anti-B7-H3 ADC

Primary outcome measure

  • Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) for patients treated with MX006 [ Time Frame: From ICF signature until 30 days (AEs) and 90 days (SAEs) after last dose of MX006 ]
  • Number of participants who experience a clinically significant change from baseline safety laboratory values [ Time Frame: Collected from screening until end of treatment and 30 days follow-up ]
  • Frequency of dose interruptions and dose reductions for patients treated with MX006. [ Time Frame: From first dose until last dose, up to 1 year ]
  • Incidence of dose limiting toxicities (DLTs) (dose-escalation only) for patients treated with MX006. [ Time Frame: DLTs are collected during the first treatment cycle (21 days) ]
  • Number of participants who experience a clinically significant change from baseline in Eastern Cooperative Group Oncology (ECOG) performance status [ Time Frame: Collected from screening until end of treatment and 30 days follow-up ]
  • Number of participants who experience a clinically significant change from baseline in 12-lead electrocardiograph (ECG) measurements [ Time Frame: Collected from screening until end of treatment and 30 days follow-up ]
  • Number of participants who experience a clinically significant change from baseline in blood pressure (vital signs) [ Time Frame: Collected from screening until end of treatment and 30 days follow-up ]
  • Number of participants who experience a clinically significant change from baseline in heart rate (vital signs) [ Time Frame: Collected from screening until end of treatment and 30 days follow-up ]
  • Number of participants who experience a clinically significant change from baseline in respiratory rate (vital signs) [ Time Frame: Collected from screening until end of treatment and 30 days follow-up ]
  • Number of participants who experience a clinically significant change from baseline in body temperature (vital signs) [ Time Frame: Collected from screening until end of treatment and 30 days follow-up ]

Central Contacts and Locations

Central contacts

Myricx Pharma Contact for Clinical Trial Information

+44 20 3103 6865clinicaltrialsinfo@myricxbio.com

Myricx Pharma Contact for Clinical Trial Information (Back-up)

+44 20 3103 6865clinicaltrialsinfo@myricxbio.com

Locations

Florida Cancer Specialists

Recruiting

Sarasota, Florida, United States, 34232

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

NEXT Oncology

Recruiting

San Antonio, Texas, United States, 78229

NEXT Oncology Virginia

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Myricx Pharma Limited

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • Advanced solid tumor
  • Advanced metastatic tumor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Myricx Pharma Limited on 2026-09-08.