NCT02262455

Brief Summary

This is a Phase I study to test the safety, pharmacokinetics and effectiveness of STM 434 alone, or in combination with liposomal doxorubicin, in patients with ovarian cancer or other advanced solid tumors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_1 ovarian-cancer

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2017

Completed
Last Updated

February 13, 2017

Status Verified

February 1, 2017

Enrollment Period

2.3 years

First QC Date

September 29, 2014

Last Update Submit

February 10, 2017

Conditions

Ovarian CancerFallopian Tube CancerEndometrial CancerSolid Tumors

Keywords

Serous tumorGranulosa tumorClear Cell tumorEndometrial cancerAdvanced solid tumorsAdenocarcinomaProstate cancerHead and Neck cancerLung cancerNon-small cell lung cancerSmall cell lung cancerGastric cancerKidney cancerPancreatic cancerBreast cancerColorectal cancerBladder cancerEsophagus cancerLiver cancerHepatobiliary cancerSkin cancer

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD)

    To define the maximum tolerated dose (MTD) of STM 434 administered alone or in combination with liposomal doxorubicin chemotherapy in patients with ovarian cancer or other advanced solid tumors.

    MTD will be assessed for STM 434 alone in Part 1 and in combination with liposomal doxorubicin in Part 3 once the last subject in each cohort completes 28 days of treatment.

Secondary Outcomes (3)

  • Recommended Phase 2 dose (RP2D)

    RP2D will be assessed in Part 1 once the last subject in each cohort completes 28 days of treatment.

  • Radiographic response rate

    Efficacy parameters will be assessed at three points in the study: once Part 1 and Part 3 are fully enrolled, and during Part 2 of the study. On average the review is expected to occur once every 8 months, for up to 24 months.

  • Muscle function and body composition

    Efficacy parameters will be assessed at three points in the study: once Part 1 and Part 3 are fully enrolled, and during Part 2 of the study. On average the review is expected to occur once every 8 months for up to 24 months.

Study Arms (2)

STM 434

EXPERIMENTAL
Drug: STM 434

STM 434 and Liposomal Doxorubicin

EXPERIMENTAL
Drug: STM 434Drug: Liposomal doxorubicin

Interventions

STM 434DRUG

STM 434 will be administered by IV injection. There are five planned dose levels, from 0.25mg/kg to 4mg/kg, which is dependent on the cohort (group) a participant is assigned to.

STM 434STM 434 and Liposomal Doxorubicin
Liposomal doxorubicinDRUG

Liposomal doxorubicin (40 mg/m2) will be administered once every 28 days by IV infusion prior to STM 434 for those participants enrolled in Part 3 of the trial. Liposomal doxorubicin will be administered for a maximum of 6 cycles (each cycle being 28 days).

STM 434 and Liposomal Doxorubicin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and postmenopausal females, 18 years or older
  • Advanced solid tumors with histologic diagnosis confirming cancer
  • Patients with recurrent metastatic or locally advanced disease considered refractory or intolerant to all standard treatment available for their tumor, or those tumors for which no standard treatment is available
  • Subjects with serous ovarian/fallopian tube/primary peritoneal, granulosa cell tumors or clear cell tumors considered platinum refractory/resistant, defined as having at least one prior platinum-based chemotherapeutic regimen with a subsequent platinum-free interval of \< 12 months, having progression during platinum-based therapy, or having persistent disease after a platinum-based therapy, are eligible. Intolerant subjects, defined as unable to receive further platinum due to toxicity, are eligible.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Informed consent

You may not qualify if:

  • History of gastrointestinal bleeding within the past 6 months
  • History of epistaxis requiring medical/surgical intervention (such as nasal packing) within the past 6 months
  • History of central nervous system hemorrhage
  • History of bleeding diathesis or known qualitative platelet defect (including von Willebrand disease)
  • Ongoing need for therapeutic anticoagulants (full dose heparin, warfarin, factor Xa or direct thrombin inhibitors; rivaroxaban, apixaban, dabigatran) chronic use of aspirin or anti-platelet agents (ticlopidine or clopidogrel)
  • History of hereditary hemorrhagic telangiectasia (HHT, Osler-Weber-Rendu syndrome)
  • Myocardial infarction, unstable angina within the past 6 months, or congestive heart failure New York Heart Association Class II or greater
  • Chemotherapy, hormonal therapy or radiation therapy within the past 3 weeks, antibody/biologic therapy within 5 half-lives or within the past 4 weeks (whichever is longer)
  • Current bowel obstruction
  • Brain metastasis
  • Known HIV infection and/or active Hepatitis B or C infection
  • Prior treatment with any investigational product within the past 4 weeks
  • Not willing to use contraception (inclusive of abstinence)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dana Farber Cancer Institute

Boston, Massachusetts, 02114, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

Related Publications (2)

  • Bian X, Snow ZK, Zinn CJ, Gowan CC, Conley SM, Bratulin AL, Elhusseiny KM, Miller J, Tchkonia T, Kirkland JL, Lerman LO, Hickson LJ. Activin A Antagonism with Follistatin Reduces Kidney Fibrosis, Injury, and Cellular Senescence-Associated Inflammation in Murine Diabetic Kidney Disease. Kidney360. 2025 Mar 28;6(8):1278-1291. doi: 10.34067/KID.0000000776.

    PMID: 40152935DERIVED

  • Tao JJ, Cangemi NA, Makker V, Cadoo KA, Liu JF, Rasco DW, Navarro WH, Haqq CM, Hyman DM. First-in-Human Phase I Study of the Activin A Inhibitor, STM 434, in Patients with Granulosa Cell Ovarian Cancer and Other Advanced Solid Tumors. Clin Cancer Res. 2019 Sep 15;25(18):5458-5465. doi: 10.1158/1078-0432.CCR-19-1065. Epub 2019 May 8.

    PMID: 31068369DERIVED

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube NeoplasmsEndometrial NeoplasmsAdenocarcinomaProstatic NeoplasmsHead and Neck NeoplasmsLung NeoplasmsCarcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaStomach NeoplasmsKidney NeoplasmsPancreatic NeoplasmsBreast NeoplasmsColorectal NeoplasmsUrinary Bladder NeoplasmsEsophageal NeoplasmsLiver NeoplasmsSkin Neoplasms

Interventions

liposomal doxorubicin

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube DiseasesUterine NeoplasmsUterine DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesMale Urogenital DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesUrologic NeoplasmsKidney DiseasesUrologic DiseasesPancreatic DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal DiseasesUrinary Bladder DiseasesEsophageal DiseasesLiver Diseases

Study Officials

  • Willis Navarro, MD

    Santa Maria Biotherapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2014

First Posted

October 13, 2014

Study Start

October 1, 2014

Primary Completion

January 13, 2017

Study Completion

January 13, 2017

Last Updated

February 13, 2017

Record last verified: 2017-02

Locations

US(4)