NCT04734262 (SPARK) is a Phase 2 clinical trial of Sitravatinib in Metastatic Breast Cancer, sponsored by Fudan University.

Who is sponsoring NCT04734262?

NCT04734262 is sponsored by Fudan University.

What drugs are being tested in NCT04734262?

Interventions in NCT04734262: Sitravatinib, Tislelizumab, Nab-paclitaxel.

What condition does NCT04734262 study?

NCT04734262 studies Metastatic Breast Cancer.

Is NCT04734262 still recruiting?

NCT04734262 is currently status unknown. Last updated 18 November 2023.

Last reviewed 2023-11-18 · How we verify

NCT04734262: SPARK

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase II Study to Explore the Safety, Tolerability, and Preliminary Antitumor Activity of Sitravatinib Plus Tislelizumab or Combination With Nab-paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC)

Status unknown Phase 2 Last updated 18 November 2023

What this trial tests

Phase 2 trial testing Sitravatinib in Metastatic Breast Cancer in 98 participants. Status unknown.

Timeline

1 April 2021

Primary endpoint
30 June 2024

30 June 2024

Quick facts

Lead sponsor	Fudan University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	98
Start date	1 April 2021
Primary completion	30 June 2024
Estimated completion	30 June 2024
Sites	1 location across China

Drugs / interventions tested

Sitravatinib (sitravatinib) — full drug profile →
Tislelizumab (TISLELIZUMAB) — full drug profile →
Nab-paclitaxel (nab-paclitaxel) — full drug profile →

Conditions studied

Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →

Sponsor

Fudan University

Who can join

18 and older, female only, with Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to assess the efficacy and safety of sitravatinib plus tislelizumab or combination with nab-paclitaxel in locally recurrent or metastatic triple-negative breast cancer (TNBC) patients.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

AXL in cancer: a modulator of drug resistance and therapeutic target.
Tang Y, Zang H, Wen Q, Fan S. · · 2023 · cited 75× · PMID 37328828 · DOI 10.1186/s13046-023-02726-w
Dissecting the Role of AXL in Cancer Immune Escape and Resistance to Immune Checkpoint Inhibition.
Engelsen AST, Lotsberg ML, Abou Khouzam R, Thiery JP, et al · · 2022 · cited 74× · PMID 35572601 · DOI 10.3389/fimmu.2022.869676
Therapeutic Targeting of the Gas6/Axl Signaling Pathway in Cancer.
Tanaka M, Siemann DW. · · 2021 · cited 60× · PMID 34576116 · DOI 10.3390/ijms22189953
AXL signaling in cancer: from molecular insights to targeted therapies.
Yadav M, Sharma A, Patne K, Tabasum S, et al · · 2025 · cited 42× · PMID 39924521 · DOI 10.1038/s41392-024-02121-7
Targeting Receptor Tyrosine Kinases as a Novel Strategy for the Treatment of Triple-Negative Breast Cancer.
Jaradat SK, Ayoub NM, Al Sharie AH, Aldaod JM. · · 2024 · cited 17× · PMID 38389413 · DOI 10.1177/15330338241234780
The Combination of Immune Checkpoint Blockade with Tumor Vessel Normalization as a Promising Therapeutic Strategy for Breast Cancer: An Overview of Preclinical and Clinical Studies.
Melaiu O, Vanni G, Portarena I, Pistolese CA, et al · · 2023 · cited 14× · PMID 36834641 · DOI 10.3390/ijms24043226
The Present and Future of Clinical Management in Metastatic Breast Cancer.
Lin PH, Laliotis G. · · 2022 · cited 14× · PMID 36233758 · DOI 10.3390/jcm11195891
Two-Front War on Cancer-Targeting TAM Receptors in Solid Tumour Therapy.
Mikolajczyk A, Mitula F, Popiel D, Kaminska B, et al · · 2022 · cited 13× · PMID 35626092 · DOI 10.3390/cancers14102488

Verify or expand the search:

Other trials of Sitravatinib

Trials testing the same drug.

NCT05564338 — Efficacy and Safety of Sitravatinib Plus Tislelizumab or Placebo Plus Tislelizumab Versus Placebo as Adjuvant Treatment · Phase 3 · withdrawn
NCT05461794 — Study To Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Participants With Esoph · Phase 2 · terminated
NCT04904302 — Sitravatinib and Nivolumab for the Treatment of Metastatic or Advanced Clear Cell Renal Cell Cancer · Phase 2 · terminated
NCT05228496 — A Study to Investigate the Efficacy and Safety of Tislelizumab Combined With Sitravatinib as Maintenance Therapy for ES- · Phase 2 · unknown
NCT04925986 — Sitravatinib Plus Pembrolizumab in Patients With Advanced Treatment-Naïve PD-L1+ Non-Squamous NSCLC · Phase 2 · terminated

Other recruiting trials for Metastatic Breast Cancer

Currently open trials in the same condition.

NCT07524855 — A Study of HLD-0117 in Patients With Metastatic Breast Cancer · Phase 1 · recruiting
NCT07408089 — Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer · Phase 1 · recruiting
NCT07340541 — Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies · Phase 2 · recruiting
NCT07233928 — Breast Cancer Organelle Properties and Protein Expression Atlas in the Three Immunohistochemical Subtypes of Breast Canc · NA · recruiting
NCT07347600 — A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, · recruiting

Other Fudan University trials

Trials by the same sponsor.

NCT06196671 — Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer · Phase 2 · not yet recruiting
NCT07423611 — ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer · Phase 2 · not yet recruiting
NCT07410559 — Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Bre · Phase 2 · not yet recruiting
NCT07490119 — Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer · Phase 2 · not yet recruiting
NCT07497919 — A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04734262 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fudan University
Last refreshed: 18 November 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04734262.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing