An Open-Label Multiple Ascending Dose Phase 1/1B Pharmacokinetic and Pharmacodynamic Study of STM 434, an Activin Type 2B Receptor Fc Fusion, Alone and in Combination With Liposomal Doxorubicin in Patients With Ovarian Cancer or Other Advanced Solid Tumors

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.

Start Date01 Oct 2014

Sponsor / Collaborator

Santa Maria Biotherapeutics, Inc.

100 Clinical Results associated with STM-434

100 Translational Medicine associated with STM-434

100 Patents (Medical) associated with STM-434

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15 Sep 2019·Clinical Cancer ResearchQ1 · MEDICINE

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

Q1 · MEDICINE

Article

Author: Tao, Jessica J. ; Hyman, David M. ; Cangemi, Nicholas A. ; Cadoo, Karen A. ; Liu, Joyce F. ; Haqq, Christopher M. ; Makker, Vicky ; Navarro, Willis H. ; Rasco, Drew W.

AbstractPurpose:STM 434 is a soluble receptor ligand trap targeting activin A, a protein in the TGFβ family that plays important roles in growth, differentiation, and cancer cachexia. This study evaluated the safety, antitumor activity, and metabolic effects of STM 434 in a first-in-human, multicenter, phase I clinical trial (NCT02262455).Patients and Methods:Patients with advanced solid tumors were enrolled in 8 dose cohorts ranging from 0.25 mg/kg every 4 weeks to 8 mg/kg every 2 weeks via a 3 + 3 dose-escalation design. The primary endpoint was maximum tolerated dose (MTD). Secondary endpoints included safety, pharmacokinetics, and response. As activin A is implicated in metabolism and muscle function, changes in key metabolic parameters, including lean body mass and 6-minute walk test, were serially measured.Results:Thirty-two patients were treated on study. The most common treatment-related adverse events were fatigue (41%) and mucocutaneous bleeding complications including epistaxis (34%) and gingival bleeding (22%), likely related to off-target inhibition of bone morphogenetic protein 9 (BMP9). STM 434 treatment resulted in the expected follicle-stimulating hormone level decreases in most patients and in metabolic parameter changes, including an increase in total lean body mass and 6-minute walk test distance. No responses were observed in the 30 evaluable patients, but the stable disease rate in patients with granulosa cell ovarian cancer was 10 of 12 (80%).Conclusions:Although no direct antitumor efficacy was documented, potentially clinically meaningful dose-related metabolic effects, including treatment of cancer cachexia, were observed that support further exploration of activin A inhibitors that limit BMP9 blockade.See related commentary by Bonilla and Oza, p. 5432

100 Deals associated with STM-434

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Ovarian Cancer	Phase 1	-	Amgen, Inc.	-
Advanced Malignant Solid Neoplasm	Discovery	US	Santa Maria Biotherapeutics, Inc.	01 Oct 2014
Endometrial Carcinoma	Discovery	US	Santa Maria Biotherapeutics, Inc.	01 Oct 2014
Fallopian Tube Carcinoma	Discovery	US	Santa Maria Biotherapeutics, Inc.	01 Oct 2014

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02262455 (Pubmed \| Clin Cancer Res)	Phase 1	Granulosa Cell Tumor of the Ovary \| Solid tumor	32	STM 434	gbajjsqcjc(nojbaphclw) = increase hltjzhlzrb (snknrwlraz ) View more	-	15 Sep 2019
AACR2018	Not Applicable	Granulosa Cell Tumor of the Ovary \| HR-positive/HER2-low Solid Tumors	32	STM434	(mbxwmcskxq) = gpiafekfos aprudujgpp (cvxzfdshst ) View more	-	01 Jul 2018
NCT02262455 (ASCO2016)	Phase 1	Granulosa Cell Tumor of the Ovary \| HR-positive/HER2-low Solid Tumors	22	STM 434	(kvzkhgmakr) = n = 6 sfcnyydtri (htrvdjjddj ) View more	Positive	20 May 2016

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