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Tobemstomig

Phase 2

Breast Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: Aug 10, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment83

FDA Designations

No designations recorded

Clinical trial landscape

Tobemstomig · 3 trials · 3 indications

Phase 2 3
NCT05852691A Study of Tobemstomig + Nab-Paclitaxel Compared With Pembrolizumab + Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast CancerBreast Cancer
ACTIVE NOT_RECRUITING83 Analytics
NCT05805501A Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Participants With Untreated Locally Advanced Unresectable or Metastatic Renal Cell CarcinomaRenal Cell Carcinoma
ACTIVE NOT_RECRUITING199 Analytics
NCT05775289A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung CancerNon-small Cell Lung Cancer
COMPLETED182 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Study of Tobemstomig + Nab-Paclitaxel Compared With Pembrolizumab + Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer
Breast CancerUnlock trial analytics
PHASE2ACTIVE NOT_RECRUITING
A Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Participants With Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma
Renal Cell CarcinomaUnlock trial analytics
PHASE2COMPLETED
A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer
Non-small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-Free Survival (PFS)
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 24 months)
Incidence and Severity of Adverse Events (AEs)
Up to a maximum of 2 years
Objective Response Rate (ORR)
Up to approximately 15 months

ORR is defined as the percentage of participants who experience a complete reponse or partial response on two consecutive occasions at least 4 weeks apart as determined by the investigator according to RECIST v1.1.

Secondary Endpoints

Objective Response Rate (ORR)
Two consecutive occasions at least 4 weeks apart (up to approximately 24 months)
Duration of Response (DOR)
From the first occurrence of a confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 24 months)
Overall Survival (OS)
From randomization to death from any cause (up to approximately 24 months)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm AEXPERIMENTALParticipants will receive tobemstomig every 3 weeks, plus nab-paclitaxel administered on a repeating schedule of 3 weeks on, 1 week off, until disease progression or until up to 24 months after the first treatment, whichever is sooner.
Arm BACTIVE_COMPARATORParticipants will receive pembrolizumab every 3 weeks, plus nab-paclitaxel administered on a repeating schedule of 3 weeks on, 1 week off, until disease progression or until up to 24 months after the first treatment, whichever is sooner.
Arm A (Tobemstomig + Axitinib)EXPERIMENTALParticipants will receive intravenous (IV) tobemstomig every three weeks (Q3W) on Day 1 of each 21-day cycle. Participants will also receive oral (PO) axitinib twice daily (BID).
Arm B (Tobemstomig + Tiragolumab + Axitinib)EXPERIMENTALParticipants will receive IV tobemstomig followed by IV tiragolumab Q3W on Day 1 of 21-day cycle. Participants will also receive axitinib PO BID.
Control Arm (Pembrolizumab + Axitinib)ACTIVE_COMPARATORParticipants will receive IV pembrolizumab Q3W on Day 1 of each 21-day cycle. Participants will also receive axitinib PO BID.
Arm A: Tobemstomig + Platinum-Based ChemotherapyEXPERIMENTALParticipants with non-squamous (NSQ) NSCLC will receive induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin, all on Day 1 every 3 weeks (Q3W) for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig together with pemetrexed until disease progression or treatment discontinuation. Participants with squamous (SQ) NSCLC will receive blinded tobemstomig in combination with paclitaxel and carboplatin, all on Day 1 Q3W for four 21 day cycles, followed by blinded tobemstomig (on Day 1) Q3W until disease progression or treatment discontinuation.
Arm B: Pembrolizumab + Platinum-Based ChemotherapyACTIVE_COMPARATORParticipants with NSQ NSCLC will receive induction treatment with blinded pembrolizumab in combination with pemetrexed and carboplatin, all on Day 1 Q3W for four 21-day cycles, followed by a maintenance therapy with blinded pembrolizumab together with pemetrexed Q3W until disease progression or treatment discontinuation. Participants with SQ NSCLC will receive blinded pembrolizumab in combination with paclitaxel and carboplatin, all on Day 1 Q3W for four 21-day cycles, followed by blinded pembrolizumab (on Day 1) Q3W until disease progression or treatment discontinuation.

Interventions

NameTypeDescription
TobemstomigDRUGParticipants will receive intravenous (IV) tobemstomig every 3 weeks (Q3W) until disease progression or until up to 24 months after the first treatment, whichever is sooner.
PembrolizumabDRUGParticipants will receive IV pembrolizumab Q3W until disease progression or until up to 24 months after the first treatment, whichever is sooner.
Nab-PaclitaxelDRUGParticipants will receive IV nab-paclitaxel weekly for 3 weeks, followed by 1 week off, until disease progression or until up to 24 months after the first treatment, whichever is sooner.
TiragolumabDRUGParticipants will receive IV tiragolumab Q3W.
AxitinibDRUGParticipants will receive axitinib PO BID.
PaclitaxelDRUGParticipants will receive IV paclitaxel Q3W for four 21-day cycles
PemetrexedDRUGParticipants will receive IV pemetrexed Q3W until disease progression or unacceptable toxicity
CarboplatinDRUGParticipants will receive IV carboplatin Q3W for four 21-day cycles
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites36

Inclusion Criteria: * Metastatic or locally advanced unresectable, histologically documented triple-negative breast cancer (TNBC) (absence of HER2-over-expression, ER, and PgR expression by local assessment) * HER2-low-status * Measurable disease per Response Evaluation Criteria in Solid Tumors (RE...

Countries:United StatesArgentinaAustraliaBrazilCzechiaGermanyHungaryIsraelItalyMexicoPeruPolandSouth AfricaSouth KoreaSpainTaiwanChinaFranceUnited KingdomBelgiumTurkey (Türkiye)
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Competitive Landscape -Breast Cancer 402 trials

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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Recent Changes (Last 90 Days)

MEDIUMAug 20, 2026NCT05775289TRIAL_REMOVED: changed
MEDIUMAug 20, 2026NCT05775289TRIAL_REMOVED: changed
MEDIUMAug 20, 2026NCT05775289TRIAL_REMOVED: changed
MEDIUMAug 20, 2026NCT05775289TRIAL_REMOVED: changed
LOWAug 11, 2026NCT05805501primaryCompletionDate: changed
LOWAug 11, 2026NCT05805501primaryCompletionDate: changed
LOWAug 11, 2026NCT05805501primaryCompletionDate: changed

Frequently asked questions about Tobemstomig

What is Tobemstomig used for?

Tobemstomig is an investigational small molecule being studied for the treatment of breast cancer, non-small cell lung cancer, and renal cell carcinoma. It is currently in Phase 2 clinical development for these oncology indications.

Who makes Tobemstomig?

Tobemstomig is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug in multiple cancer types.

What phase is Tobemstomig in?

Tobemstomig is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing or completed to assess its safety and efficacy in various cancers.

What clinical trials is Tobemstomig in?

Tobemstomig is being studied in three Phase 2 trials. NCT05775289 evaluates it with chemotherapy in non-small cell lung cancer. NCT05805501 tests it in combination with axitinib for renal cell carcinoma. NCT05852691 studies it with nab-paclitaxel in triple-negative breast cancer.

Is Tobemstomig being studied in breast cancer?

Yes, Tobemstomig is being studied in breast cancer. A Phase 2 trial, NCT05852691, is evaluating Tobemstomig plus nab-paclitaxel compared with pembrolizumab plus nab-paclitaxel in participants with previously untreated, PD-L1-positive, locally advanced unresectable or metastatic triple-negative breast cancer.

Is Tobemstomig being studied in non-small cell lung cancer?

Yes, Tobemstomig is being studied in non-small cell lung cancer. A Phase 2 trial, NCT05775289, compares Tobemstomig plus platinum-based chemotherapy with pembrolizumab plus platinum-based chemotherapy in participants with previously untreated non-small cell lung cancer.