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Torvutatug samrotecan

Phase 1

Ovarian Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Aug 21, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment602

FDA Designations

No designations recorded

Clinical trial landscape

Torvutatug samrotecan · 1 trial · 4 indications

Phase 1 1
NCT05797168Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid TumorsOvarian Cancer
RECRUITING602 Analytics
PHASE1RECRUITING
Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors
Ovarian CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with adverse events/serious adverse events
From time of Informed Consent to 30 days post last dose.

Number of participants with incidence of adverse events and with serious adverse events including changes from baseline in laboratory parameters, vital signs, ECGs, and physical examination.

The number of participants with dose limiting toxicity(DLT), as defined in the protocol
From the first dose of torvu-sam on Cycle 1 Day 1 up to and including the planned end of Cycle 1 (At the end of 21 days)

A DLT is defined as any ≥ Grade 3 treatment-emergent AE that occurs during the DLT evaluation period, not attributable to the underlying disease or extraneous causes (as defined in the protocol)

Secondary Endpoints

Objective Response Rate (ORR)
From time of Informed Consent to progressive disease or withdrawal of consent.(approx 2 years)
Duration of Response (DoR)
From the first documented response to confirmed progression or death in the absence of disease progression.(approx 2 years)
Disease Control Rate (DCR)
From time of Informed Consent until progression.(approx 15 weeks)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Module 1: Torvu-sam MonotherapyEXPERIMENTALTorvu-sam Monotherapy
Module 2: Torvu-sam + SaruparibEXPERIMENTALTorvu-sam + Saruparib
Module 3: Torvu-sam + BevacizumabEXPERIMENTALTorvu-sam + Bevacizumab
Module 4: Torvu-sam + Carboplatin +/- BevacizumabEXPERIMENTALTorvu-sam + Carboplatin +/- Bevacizumab
Module 5: Torvu-sam + Palacaparib +/- BevacizumabEXPERIMENTALTorvu-sam + Palacaparib +/- Bevacizumab
Module 6: Torvu-sam + Pembrolizumab +/- PalacaparibEXPERIMENTALTorvu-sam + Pembrolizumab +/- Palacaparib

Interventions

NameTypeDescription
Torvutatug samrotecanDRUGIV Antibody-drug conjugate
SaruparibDRUGOral PARP inhibitor
BevacizumabDRUGIV Monoclonal antibody
CarboplatinDRUGIV Alkylating agent
PalacaparibDRUGOral PARP inhibitor
PembrolizumabDRUGIV Biologic
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Eligibility Criteria

Age Range18 Years to 130 Years
SexALL
Healthy VolunteersNo
Study Sites60

Core Inclusion Criteria: * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. * Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of sample...

Countries:United StatesAustraliaCanadaChinaGermanyIsraelJapanSouth KoreaSpainTaiwanTurkey (Türkiye)United Kingdom
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Competitive Landscape -Ovarian Cancer 176 trials

Top 20 of 59 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK5PHASE3Pembrolizumab, Paclitaxel, Bevacizumab, Docetaxel
AstraZeneca PLCAZN19PHASE3Olaparib
GSK plc Sponsored ADRGSK4PHASE3Niraparib
Eli Lilly and CompanyLLY8PHASE3Sofetabart Mipitecan, Paclitaxel, Topotecan, Gemcitabine, Pegylated liposomal doxorubicin
AbbVie, Inc.ABBV13PHASE3Mirvetuximab soravtansine plus Bevacizumab, Bevacizumab
Bristol-Myers Squibb CompanyBMY4PHASE3Rucaparib, Nivolumab
Genmab A/S Sponsored ADRGMAB5PHASE3Rina-S, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin, Gemcitabine
Pfizer Inc.PFE4PHASE3Avelumab, Lorlatanib, Talazoparib, Pemetrexed, Axitinib
Corcept Therapeutics Incorporated.CORT2PHASE3Nab-paclitaxel/m^2, Relacorilant once daily
Verastem, Inc.VSTM4PHASE3avutometinib, Defactinib, Pegylated liposomal doxorubicin, Paclitaxel, Letrozole
Zentalis Pharmaceuticals, Inc.ZNTL3PHASE3Azenosertib
Imunon, Inc.IMNN3PHASE3IMNN-001, Paclitaxel, Carboplatin, Olaparib, Niraparib
Incyte CorporationINCY2PHASE3INCB123667
Genelux Corp.GNLX1PHASE3olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin or cisplatin, Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane or pegylated liposomal doxorubicin, Bevacizumab
Regeneron Pharmaceuticals, Inc.REGN4PHASE2Ubamatamab, Bevacizumab, Cemiplimab, Fianlimab, PLD
Novartis AG Sponsored ADRNVS4PHASE2Dabrafenib, Trametinib
BeOne Medicines Ltd. Sponsored ADRONC2PHASE3Pamiparib
IQVIA Holdings IncIQV1PHASE3Oregovomab, Paclitaxel, Carboplatin
Xencor, Inc.XNCR3PHASE2vudalimab
Exelixis, Inc.EXEL2PHASE2Cabozantinib
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Recent Changes (Last 90 Days)

LOWAug 21, 2026NCT05797168lastUpdatePostDate: changed
LOWAug 21, 2026NCT05797168lastUpdatePostDate: changed
MEDIUMJul 24, 2026NCT05797168Enrollment: 506 → 602
MEDIUMJul 24, 2026NCT05797168Enrollment: 506 → 602

Frequently asked questions about Torvutatug samrotecan

What is Torvutatug samrotecan used for?

Torvutatug samrotecan is an investigational small molecule being developed for the treatment of ovarian cancer. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in clinical trials.

What does Torvutatug samrotecan target?

Torvutatug samrotecan is a small molecule, but its specific molecular target has not been disclosed in the available information. The drug is being studied in a Phase 1 clinical trial for solid tumors, including ovarian cancer, but the exact mechanism of action is not publicly detailed.

Who makes Torvutatug samrotecan?

Torvutatug samrotecan is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca is conducting clinical trials to evaluate the drug's safety and efficacy in patients with solid tumors.

What phase is Torvutatug samrotecan in?

Torvutatug samrotecan is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies such as the FDA. The ongoing Phase 1 trial is recruiting participants to study the drug as a monotherapy and in combination therapy for solid tumors.

What clinical trials is Torvutatug samrotecan in?

Torvutatug samrotecan is being studied in a Phase 1/IIa clinical trial with the identifier NCT05797168. This trial is recruiting 602 participants with solid tumors, including ovarian cancer, lung adenocarcinoma, endometrial cancer, and lung squamous cell carcinoma. The study is being conducted across multiple countries, including the United States, Australia, Canada, China, Germany, Israel, Japan, South Korea, Spain, Taiwan, Turkey, and the United Kingdom.

Is Torvutatug samrotecan the same as AZD5335?

Yes, Torvutatug samrotecan is also known as AZD5335. The clinical trial NCT05797168, titled 'Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors,' is evaluating this drug. The trial is currently recruiting patients with various solid tumors, including ovarian cancer.