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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06956690




Registration number
NCT06956690
Ethics application status
Date submitted
24/04/2025
Date registered
4/05/2025

Titles & IDs
Public title
A Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ENV-501 in Patients With HER3-Expressing Solid Tumors
Scientific title
A First-in-Human, Open-label, Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ENV-501 in Patients With Advanced-Stage, Relapsed/Refractory HER3-Expressing Solid Tumors
Secondary ID [1] 0 0
ENV-ONC-501
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma (Skin) 0 0
Non Small Cell Lung Cancer 0 0
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - ENV-501

Experimental: ENV-501 - ENV-501 intravenous injection once every 3 weeks; successive cohorts will receive escalating doses of ENV-501 until the RP2D is reached


Treatment: Other: ENV-501
ENV-501 is a HER3-targeted antibody-drug conjugate (ADC) with a humanized monoclonal antibody (mAb) conjugated with a chemotherapeutic payload via a linker.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1 (Dose Escalation): Frequency of treatment-emergent adverse events
Timepoint [1] 0 0
through study completion, an average of 6 months
Primary outcome [2] 0 0
Phase 2 (Dose Expansion): Objective Response Rate (ORR)
Timepoint [2] 0 0
through study completion, an average of 6 months
Secondary outcome [1] 0 0
Phase 1 (Dose Escalation): Disease Control Rate (DCR)
Timepoint [1] 0 0
through study completion, an average of 6 months
Secondary outcome [2] 0 0
Phase 1 (Dose Escalation): Objective Response Rate (ORR)
Timepoint [2] 0 0
through study completion, an average of 6 months
Secondary outcome [3] 0 0
Phase 1 (Dose Escalation): maximum blood concentration (Cmax) after a single dose
Timepoint [3] 0 0
At the end of Cycle 1 (each cycle is 21 days)
Secondary outcome [4] 0 0
Phase 1 (Dose Escalation): time of maximum blood concentration (Tmax) after a single dose
Timepoint [4] 0 0
At the end of Cycle 1 (each cycle is 21 days)
Secondary outcome [5] 0 0
Phase 1 (Dose Escalation): absorption to time t (AUC0-t) after a single dose
Timepoint [5] 0 0
At the end of Cycle 1 (each cycle is 21 days)
Secondary outcome [6] 0 0
Phase 1 (Dose Escalation): absorption to end of the dosing period (AUC0-tau) after a single dose
Timepoint [6] 0 0
At the end of Cycle 1 (each cycle is 21 days)
Secondary outcome [7] 0 0
Phase 1 (Dose Escalation): total absorption (AUC0-infinity) after a single dose
Timepoint [7] 0 0
At the end of Cycle 1 (each cycle is 21 days)
Secondary outcome [8] 0 0
Phase 1 (Dose Escalation): drug half-life (t1/2) after a single dose
Timepoint [8] 0 0
At the end of Cycle 1 (each cycle is 21 days)
Secondary outcome [9] 0 0
Phase 1 (Dose Escalation): minimum blood concentration (Cmin) after a single dose
Timepoint [9] 0 0
At the end of Cycle 1 (each cycle is 21 days)
Secondary outcome [10] 0 0
Phase 1 (Dose Escalation): rate of clearance (CL) after a single dose
Timepoint [10] 0 0
At the end of Cycle 1 (each cycle is 21 days)
Secondary outcome [11] 0 0
Phase 1 (Dose Escalation): steady-state volume of distribution (Vss) after a single dose
Timepoint [11] 0 0
At the end of Cycle 1 (each cycle is 21 days)
Secondary outcome [12] 0 0
Phase 1 (Dose Escalation): Cmax at steady state
Timepoint [12] 0 0
through study completion, an average of 6 months
Secondary outcome [13] 0 0
Phase 1 (Dose Escalation): Tmax at steady state
Timepoint [13] 0 0
through study completion, an average of 6 months
Secondary outcome [14] 0 0
Phase 1 (Dose Escalation): AUC0-t at steady state
Timepoint [14] 0 0
through study completion, an average of 6 months
Secondary outcome [15] 0 0
Phase 1 (Dose Escalation):AUC0-tau at steady state
Timepoint [15] 0 0
through study completion, an average of 6 months
Secondary outcome [16] 0 0
Phase 1 (Dose Escalation): t1/2 at steady state
Timepoint [16] 0 0
through study completion, an average of 6 months
Secondary outcome [17] 0 0
Phase 1 (Dose Escalation): Cmin at steady state
Timepoint [17] 0 0
through study completion, an average of 6 months
Secondary outcome [18] 0 0
Phase 1 (Dose Escalation): accumulation ratio at steady state
Timepoint [18] 0 0
through study completion, an average of 6 months
Secondary outcome [19] 0 0
Phase 2 (Dose Expansion): Disease Control Rate (DCR)
Timepoint [19] 0 0
through study completion, an average of 6 months
Secondary outcome [20] 0 0
Phase 2 (Dose Expansion): Duration of Response (DoR)
Timepoint [20] 0 0
through study completion, an average of 6 months
Secondary outcome [21] 0 0
Phase 2 (Dose Expansion): Progression-free Survival (PFS)
Timepoint [21] 0 0
through study completion, an average of 6 months
Secondary outcome [22] 0 0
Phase 2 (Dose Expansion): Frequency of treatment-emergent adverse events
Timepoint [22] 0 0
through study completion, an average of 6 months
Secondary outcome [23] 0 0
Phase 2 (Dose Expansion): Cmax at steady state
Timepoint [23] 0 0
through study completion, an average of 6 months
Secondary outcome [24] 0 0
Phase 2 (Dose Expansion): Cmin at steady state
Timepoint [24] 0 0
through study completion, an average of 6 months

Eligibility
Key inclusion criteria
* Body weight = 40 kg.
* Willing and able to provide signed written informed consent before any study-related screening procedures are performed.
* Patients with histologically or cytologically confirmed diagnosis of advanced-stage or metastatic HER3+ solid tumors that are relapsed or refractory to or ineligible for standard therapy, or for whom no standard therapy is available; or the patient has documented their refusal of standard of care therapies. These include the following:

1. Unresectable or metastatic cutaneous melanoma (HER3+)
2. Locally advanced or metastatic mutated EGFR (mEGFR) NSCLC (HER3+)
3. Unresectable, locally advanced or metastatic hormone receptor (HR)+/human epidermal growth factor receptor 2 (HER2)- breast cancer (HER3+)
* If molecular pathology report to confirm HER3+ status is not available, willingness to undergo fresh tumor biopsy for assessment of HER3+ status.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
* Contraceptive requirements:

1. Women of childbearing potential (WOCBP) must use contraception from at least 28 days prior to study start, during the study, and for at least 6 months after the last dose of study drug.
2. Males who are sexually active with partner(s) who are WOCBP must agree to use a male condom with spermicide beginning at study start, during the study and for at least 6 months after the last dose of study drug.
* Females must:

1. Agree to not donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 6 months after the last dose of study drug.
2. Agree to not breastfeed and do not plan to become pregnant during the study and for at least 6 months after the last dose of study drug.
* Males must:

1. Agree to not donate sperm beginning at study start, during the study, and for at least 6 months after the last dose of study drug.
2. Agree to not plan to father a child beginning at study start, during the study, and for at least 6 months after last dose of study drug.
* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any of the following treatment interventions within the specified time frame prior to study drug administration at study start:

1. Any anti-tumor-directed drug therapy within 21 days or 5 times the elimination half-life (whichever is shorter).
2. Treatment with investigational drugs within 21 days.
3. Major surgery within 21 days.
4. Radiation therapy =4 weeks or radiotherapy that included >30% of the bone marrow.
5. Autologous or allogeneic stem cell transplantation or allogeneic tissue/organ transplant within 3 months.
6. CYP3A4 strong inhibitor (including any prescription or non-prescription drugs or herbal supplements) =4 half-lives.
7. CYP3A4 strong inducer =4 half-lives.
8. OATP1B inhibitor (including any prescription or non-prescription drugs or herbal supplements) =4 half-lives.
* Prior treatment with a HER3-targeted ADC or any exatecan- or exatecan-derivative-conjugated ADC inhibitor as last line of therapy.
* Prior treatment with a topoisomerase I inhibitor as last line of therapy.
* Primary immune deficiency (e.g. congenital syndromes).
* Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment within 2 weeks prior to study start.
* Known/suspected hypersensitivity against ENV-501, human or humanized immunoglobulin Gs (IgGs), or their ingredients.
* History of noninfectious or drug-induced pneumonitis or interstitial lung disease (ILD).
* Known seropositivity (except after vaccination or confirmed cure for hepatitis) for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
* Leptomeningeal disease, symptomatic or uncontrolled (active) brain metastasis (note: brain metastases not requiring steroids or anti-epileptic therapy are allowed if stable for =4 weeks prior to study start and patient is neurologically stable).
* Pregnant or WOCBP who have a positive b-human chorionic gonadotropin (HCG) test result at Screening or within 7 days prior to study start.
* Patients with second malignancies that are active (uncontrolled, metastatic) or requiring therapy.
* Patient who is an immediate family member (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study site or the Sponsor.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2027
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Research Site - Campbelltown
Recruitment hospital [2] 0 0
Research Site - Miranda
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
2228 - Miranda
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Endeavor Biomedicines, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lisa Lancaster, M.D.
Address 0 0
Endeavor Biomedicines
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Endeavor Clinical Trials
Address 0 0
Country 0 0
Phone 0 0
1-858-727-3199
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06956690