| 2026-02-18 01:00:46 |
statusModule.statusVerifiedDate: 2026-01 |
statusModule.statusVerifiedDate: 2026-02 |
| 2026-02-18 01:00:46 |
statusModule.lastUpdateSubmitDate: 2026-01-16 |
statusModule.lastUpdateSubmitDate: 2026-02-16 |
| 2026-02-18 01:00:46 |
statusModule.lastUpdatePostDateStruct.date: 2026-01-20 |
statusModule.lastUpdatePostDateStruct.date: 2026-02-17 |
| 2026-02-18 01:00:46 |
contactsLocationsModule.locations.[22]city: N. Efkapria-Pavlos Melas |
contactsLocationsModule.locations.[22]city: Pavlos Melas |
| 2026-02-18 01:00:46 |
contactsLocationsModule.locations.[30]facility: ICO l?Hospitalet ? Hospital Duran i Reynals |
contactsLocationsModule.locations.[30]facility: ICO Hospitalet- Hospital Duran i Reynals |
| 2026-05-26 02:38:39 |
identificationModule.briefTitle: A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors |
identificationModule.briefTitle: A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors |
| 2026-05-26 02:38:39 |
identificationModule.officialTitle: A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors |
identificationModule.officialTitle: A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors |
| 2026-05-26 02:38:39 |
statusModule.statusVerifiedDate: 2026-02 |
statusModule.statusVerifiedDate: 2026-05 |
| 2026-05-26 02:38:39 |
statusModule.primaryCompletionDateStruct.date: 2027-02-28 |
statusModule.primaryCompletionDateStruct.date: 2028-07-31 |
| 2026-05-26 02:38:39 |
statusModule.completionDateStruct.date: 2027-02-28 |
statusModule.completionDateStruct.date: 2028-07-31 |
| 2026-05-26 02:38:39 |
statusModule.lastUpdateSubmitDate: 2026-02-16 |
statusModule.lastUpdateSubmitDate: 2026-05-08 |
| 2026-05-26 02:38:39 |
statusModule.lastUpdatePostDateStruct.date: 2026-02-17 |
statusModule.lastUpdatePostDateStruct.date: 2026-05-11 |
| 2026-05-26 02:38:39 |
descriptionModule.briefSummary: This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of RO7502175 when administered as a single agent and in combination with atezolizumab or pembrolizumab in adult participants with locally advanced or metastatic solid tumors, including non-small-cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, colorectal cancer (CRC), urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion. |
descriptionModule.briefSummary: This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of enzelkitug when administered as a single agent and in combination with atezolizumab or pembrolizumab in adult participants with locally advanced or metastatic solid tumors, including non small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, colorectal cancer (CRC), urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion. |
| 2026-05-26 02:38:39 |
- |
Field `eligibilityModule.eligibilityCriteria` changed from `Inclusion Criteria: |
| 2026-05-26 02:38:39 |
- |
* Life expectancy at least 12 weeks |
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- |
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 |
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- |
* Measurable disease according to Response Evaluation criteria in Solid Tumors (RECIST) Version 1.1 |
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* Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy |
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* Tumor Specimen availability |
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Exclusion Criteria: |
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- |
* Pregnant or breastfeeding or intention of becoming pregnant during the study or within 4 months after the final dose of RO7501275, or 4 months after the final dose of pembrolizumab, or 5 months after the final dose of atezolizumab |
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* Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment |
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* Active hepatitis B or C or tuberculosis |
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* Positive test for human immunodeficiency virus (HIV) infection |
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* Acute or chronic active Epstein-Barr virus (EBV) infection at screening |
| 2026-05-26 02:38:39 |
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* Administration of a li` to `Inclusion Criteria: |
| 2026-05-26 02:38:39 |
- |
* Life expectancy of at least 12 weeks |
| 2026-05-26 02:38:39 |
- |
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 |
| 2026-05-26 02:38:39 |
- |
* Measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) |
| 2026-05-26 02:38:39 |
- |
* Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy |
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- |
* Tumor specimen availability |
| 2026-05-26 02:38:39 |
- |
Exclusion Criteria: |
| 2026-05-26 02:38:39 |
- |
* Pregnant or breastfeeding or intention of becoming pregnant during the study or within 4 months after the final dose of enzelkitug, or 4 months after the final dose of pembrolizumab, or 5 months after the final dose of atezolizumab |
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- |
* Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment |
| 2026-05-26 02:38:39 |
- |
* Active hepatitis B (HBV) or hepatitis C (HCV) or tuberculosis |
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* Positive test for human immunodeficiency virus (HIV) infection |
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* Acute or chronic active Epstein-Barr virus (EBV) infection at` |
| 2026-05-26 02:38:39 |
outcomesModule.secondaryOutcomes.[0]: {'measure': 'Phase Ia and Phase Ib: Maximum Serum Concentration (Cmax) of RO7502175', 'timeFrame': 'From Cycle 1 (each cycle is 21 days) Day1 and at multiple timepoints up to each follow-up visits (up to approximately 5 years)'} |
outcomesModule.secondaryOutcomes.[0]: {'measure': 'Phase Ia and Phase Ib: Maximum Serum Concentration (Cmax) of Enzelkitug', 'timeFrame': 'From Cycle 1 (each cycle is 21 days) Day 1, and at multiple timepoints up to each follow-up visits (up to approximately 52 months)'} |
| 2026-05-26 02:38:39 |
armsInterventionsModule.armGroups.[2]: {'label': 'Phase Ib: Dose Escalation', 'type': 'EXPERIMENTAL', 'description': 'Participants in successive cohorts will receive escalating doses of RO7502175, as an IV infusion, in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: RO7502175', 'Drug: Atezolizumab']} |
armsInterventionsModule.armGroups.[2]: {'label': 'Phase Ib: Dose Escalation', 'type': 'EXPERIMENTAL', 'description': 'Participants in successive cohorts will receive escalating doses of enzelkitug, as an IV infusion, in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Enzelkitug', 'Drug: Atezolizumab']} |
| 2026-05-26 02:38:39 |
armsInterventionsModule.interventions.[2]: {'type': 'DRUG', 'name': 'Pembrolizumab', 'description': 'Pembrolizumab will be administered as per the schedules specified in the respective arms.', 'armGroupLabels': ['Phase Ib: Expansion']} |
armsInterventionsModule.interventions.[2]: {'type': 'DRUG', 'name': 'Pembrolizumab', 'description': 'Pembrolizumab will be administered as per the schedule specified in the respective arms.', 'armGroupLabels': ['Phase Ib: Expansion'], 'otherNames': ['Keytruda']} |
| 2026-05-26 02:38:39 |
armsInterventionsModule.armGroups.[1]: {'label': 'Phase Ia: Expansion', 'type': 'EXPERIMENTAL', 'description': 'Participants with select solid tumors will receive a recommended dose of RO7502175, determined in Phase Ia Dose Escalation phase as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: RO7502175']} |
armsInterventionsModule.armGroups.[1]: {'label': 'Phase Ia: Expansion', 'type': 'EXPERIMENTAL', 'description': 'Participants with select solid tumors will receive a recommended dose of enzelkitug, determined in Phase Ia dose escalation phase as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Enzelkitug']} |
| 2026-05-26 02:38:39 |
outcomesModule.secondaryOutcomes.[2]: {'measure': 'Phase Ia and Phase Ib: Duration of Response (DOR)', 'timeFrame': 'From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 5 years)'} |
outcomesModule.secondaryOutcomes.[2]: {'measure': 'Phase Ia and Phase Ib: Duration of Response (DOR)', 'timeFrame': 'From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 52 months)'} |
| 2026-05-26 02:38:39 |
outcomesModule.secondaryOutcomes.[1]: {'measure': 'Phase Ia and Phase Ib: Objective Response Rate (ORR)', 'timeFrame': 'From Cycle 1(each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 5 years)'} |
outcomesModule.secondaryOutcomes.[1]: {'measure': 'Phase Ia and Phase Ib: Objective Response Rate (ORR)', 'timeFrame': 'From Cycle 1(each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 52 months)'} |
| 2026-05-26 02:38:39 |
outcomesModule.primaryOutcomes.[3]: {'measure': 'Phase Ib: Number of Participants with Treatment Emergent Adverse Events', 'timeFrame': 'Up to approximately 5 years'} |
outcomesModule.primaryOutcomes.[3]: {'measure': 'Phase Ib: Number of Participants With TEAEs', 'timeFrame': 'Up to approximately 52 months'} |
| 2026-05-26 02:38:39 |
outcomesModule.primaryOutcomes.[2]: {'measure': 'Phase Ia: Number of Participants with Treatment Emergent Adverse Events', 'timeFrame': 'Up to approximately 5 years'} |
outcomesModule.primaryOutcomes.[2]: {'measure': 'Phase Ia: Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to approximately 52 months'} |
| 2026-05-26 02:38:39 |
armsInterventionsModule.interventions.[1]: {'type': 'DRUG', 'name': 'Atezolizumab', 'description': 'Atezolizumab will be administered as per the schedules specified in the respective arms.', 'armGroupLabels': ['Phase Ib: Dose Escalation', 'Phase Ib: Expansion']} |
armsInterventionsModule.interventions.[1]: {'type': 'DRUG', 'name': 'Atezolizumab', 'description': 'Atezolizumab will be administered as per the schedule specified in the respective arms.', 'armGroupLabels': ['Phase Ib: Dose Escalation', 'Phase Ib: Expansion'], 'otherNames': ['Tecentriq']} |
| 2026-05-26 02:38:39 |
- |
Field `outcomesModule.secondaryOutcomes.[4]` changed from `{'measure': 'Phase Ia and Phase Ib: Percentage of Participants With Anti-Drug Antibody (ADA) to RO7502175', 'timeFrame': 'From Cycle 1 (each cycle is 21 days) Day 1 and at multiple timepoints up to tre |
| 2026-06-10 03:50:42 |
statusModule.statusVerifiedDate: 2026-05 |
statusModule.statusVerifiedDate: 2026-06 |
| 2026-06-10 03:50:42 |
statusModule.lastUpdateSubmitDate: 2026-05-08 |
statusModule.lastUpdateSubmitDate: 2026-06-05 |
| 2026-06-10 03:50:42 |
statusModule.lastUpdatePostDateStruct.date: 2026-05-11 |
statusModule.lastUpdatePostDateStruct.date: 2026-06-09 |
| 2026-06-10 03:50:42 |
- |
root['referencesModule'] (Added) |
| 2026-07-28 00:26:03 |
statusModule.statusVerifiedDate: 2026-06 |
statusModule.statusVerifiedDate: 2026-07 |
| 2026-07-28 00:26:03 |
statusModule.lastUpdateSubmitDate: 2026-06-05 |
statusModule.lastUpdateSubmitDate: 2026-07-03 |
| 2026-07-28 00:26:03 |
statusModule.lastUpdatePostDateStruct.date: 2026-06-09 |
statusModule.lastUpdatePostDateStruct.date: 2026-07-07 |
| 2026-07-28 00:26:03 |
contactsLocationsModule.locations.[10]facility: South Texas Accelerated Research Therapeutics (START) |
contactsLocationsModule.locations.[10]facility: IDS (IDS) Pharmacist South Texas Accelerated Resear Therapeutics, LLC START |
| 2026-07-28 00:26:03 |
contactsLocationsModule.locations.[10]zip: 98229 |
contactsLocationsModule.locations.[10]zip: 78229 |
| 2026-07-28 00:26:03 |
contactsLocationsModule.locations.[22]city: Pavlos Melas |
contactsLocationsModule.locations.[22]city: N. Efkapria-Pavlos Melas |
| 2026-07-28 00:26:03 |
contactsLocationsModule.locations.[30]facility: ICO Hospitalet- Hospital Duran i Reynals |
contactsLocationsModule.locations.[30]facility: ICO l?Hospitalet ? Hospital Duran i Reynals |