Advanced and/or Metastatic Solid Tumors Known to Express B7-H3Phase 1NCT07807241
A Study of MX006 in Patients With Advanced and/or Metastatic Tumors Known to Express B7-H3
A Phase 1 study testing MX006 in people with Advanced and/or Metastatic Solid Tumors Known to Express B7-H3, run by Myricx Pharma Limited at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced and/or Metastatic Solid Tumors Known to Express B7-H3
- What is being tested?
- MX006
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 20 Jul 2026to Jul 2030
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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.
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Myricx Pharma Contact for Clinical Trial Information contact
Myricx Pharma Contact for Clinical Trial Information (Back-up) contact
7 sites in 2 countries
United States6 sites, 6 recruiting
- Recruiting
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
- Recruiting
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
- Recruiting
NEXT Oncology Virginia
Fairfax, Virginia, 22031
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
NEXT Oncology
San Antonio, Texas, 78229
- Recruiting
Florida Cancer Specialists
Sarasota, Florida, 34232
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
Official title: A Phase 1a/b, Open-label, Dose-escalation and Dose-expansion, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of MX006 in Patients With Selected Advanced Solid Tumor Types Known to Express B7-H3
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.
- Being tested
- MX006
- Keywords
- Advanced solid tumor, Advanced metastatic tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MX006Drug
Anti-B7-H3 ADC
| Study group | Role | What they receive |
|---|---|---|
| Part A: Dose escalation | Experimental | 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. Receives: Drug: MX006 |
| Part B: Dose-expansion | Experimental | 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. Receives: Drug: MX006 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Collected from screening until end of treatment and 30 days follow-up
Secondary outcomes (10)
Evaluate the preliminary anti-tumor activity of MX006
Overall response rate (ORR), duration of response (DOR), progression-free survival (PFS)
Measured: 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.
Measured: Through study completion, up to 48 months
Area under concentration time curve (AUC)
PK parameter
Measured: Day 1 to end of treatment, up to approximately 1 year
Maximum concentration of MX006 (Cmax)
PK parameter
Measured: Day 1 to end of treatment, up to approximately 1 year
Minimum concentration of MX006 (Cmin)
PK parameter
Measured: Day 1 to end of treatment, up to approximately 1 year
Time to maximum concentration of MX006 (Tmax)
PK parameter
Measured: Day 1 to end of treatment, up to approximately 1 year
Concentration of MX006 prior to next dose (Ctrough)
PK parameter
Measured: Day 1 to end of treatment, up to approximately 1 year
Terminal half-life of MX006 (t1/2)
PK parameter
Measured: Day 1 to end of treatment, up to approximately 1 year
Clearance of MX006 (CL)
PK parameter
Measured: 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
Measured: Day 1 to end of treatment, up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start20 Jul 2026
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced and/or Metastatic Solid Tumors Known to Express B7-H3Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myricx Pharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steen Lisby, MD, Study director, Myricx Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807241
- Sponsor's protocol ID
- MX006-101
- Other IDs
- 2025-524929-41-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 26 Aug 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No