RecruitingNCT07807241Updated Sep 8, 2026

A Study of MX006 in Patients With Advanced and/or Metastatic Tumors Known to Express B7-H3

A Phase 1 interventional study of MX006 in Advanced and/or Metastatic Solid Tumors Known to Express B7-H3, sponsored by Myricx Pharma Limited. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Myricx Pharma Limited · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 120
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study 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 studied

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

Keywords

Advanced solid tumor
Advanced metastatic tumor

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 120 participants (estimated)

Study 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.
Drug: MX006
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.
Drug: MX006

Interventions

DrugMX006
Anti-B7-H3 ADC

What researchers measure

Primary outcomes

Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) for patients treated with MX006
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) will be graded according to Common Terminology Criteria for Adverse Events (version 6)
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
Change from baseline
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.
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.
DLTs are dose-limiting toxicities as defined in the study protocol.
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
Measured on a scale of from grades 0-5.
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)
Measured in mm Hg
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)
Measured in beats per minutes
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)
Measured in breaths per minute
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)
Measured in degrees Celsius
Time frame: Collected from screening until end of treatment and 30 days follow-up

Secondary outcomes

Evaluate the preliminary anti-tumor activity of MX006
Overall response rate (ORR), duration of response (DOR), progression-free survival (PFS)
Time frame: From screening until end of treatment, up to 1 year (follow-up for patients who discontinue treatment for reasons other than disease progression or initiation of other cancer therapy: 6 months (Part A) or 12 months (Part B)
Overall survival (OS)
Overall survival (OS) defined as the time between the start of treatment and death from any cause for patients treated with MX006.
Time frame: Through study completion, up to 48 months
Area under concentration time curve (AUC)
PK parameter
Time frame: Day 1 to end of treatment, up to approximately 1 year
Maximum concentration of MX006 (Cmax)
PK parameter
Time frame: Day 1 to end of treatment, up to approximately 1 year
Minimum concentration of MX006 (Cmin)
PK parameter
Time frame: Day 1 to end of treatment, up to approximately 1 year
Time to maximum concentration of MX006 (Tmax)
PK parameter
Time frame: Day 1 to end of treatment, up to approximately 1 year
Concentration of MX006 prior to next dose (Ctrough)
PK parameter
Time frame: Day 1 to end of treatment, up to approximately 1 year
Terminal half-life of MX006 (t1/2)
PK parameter
Time frame: Day 1 to end of treatment, up to approximately 1 year
Clearance of MX006 (CL)
PK parameter
Time frame: Day 1 to end of treatment, up to approximately 1 year
Anti-drug antibody (ADA) response to MX006
Frequency of confirmed positive anti-drug antibody (ADA) responses, and, if applicable, neutralizing activity to MX006 after treatment with MX006
Time frame: Day 1 to end of treatment, up to approximately 1 year

Study locations

4 of 4 sites recruiting

Florida Cancer Specialists
Sarasota, Florida 34232, United States
Recruiting
MD Anderson Cancer Center
Houston, Texas 77030, United States
Recruiting
NEXT Oncology
San Antonio, Texas 78229, United States
Recruiting
NEXT Oncology Virginia
Fairfax, Virginia 22031, United States
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT07807241
Lead sponsor: Myricx Pharma Limited
Responsible party: Sponsor
First posted: Sep 8, 2026
Start date: Jul 20, 2026
Primary completion: Jul 2030 (estimated)
Completion: Jul 2030 (estimated)
Last update: Sep 8, 2026

Study contacts

Myricx Pharma Contact for Clinical Trial Information

Contact

clinicaltrialsinfo@myricxbio.com

+44 20 3103 6865

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

Contact

clinicaltrialsinfo@myricxbio.com

+44 20 3103 6865

Steen Lisby, MD

study director · Myricx Pharma

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion