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Phase 1/2a Study of SQ3370 in Patients With Advanced Solid Tumors
Phase 1, PHASE2 trial testing SQ3370 in Cancer in 53 participants. Terminated before completion.
| Lead sponsor | Shasqi, Inc. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 53 |
| Start date | 1 August 2020 |
| Primary completion | 7 September 2023 |
| Estimated completion | 7 September 2023 |
| Sites | 10 locations across United States, Australia |
Shasqi, Inc. — full company profile →
18 and older, any sex, with Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
To determine the Recommended Phase 2 Dose of SQ3370
| Group | Value | 95% CI |
|---|---|---|
| Dose Escalation Cohort (10 mL SQL70) | 1250 | |
| Dose Escalation Cohort (20 mL SQL70) | 1250 |
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| Group | Value | 95% CI |
|---|---|---|
| Cohort A (10 mL SQL70 and 185 mg/m2/Day of SQP33) | 0 | |
| Phase 2a Expansion Group 1 (Extremity STS) (10 mL SQL70 and 250 mg/m2/Day of SQP33) | 1 | |
| P2a Grp 2 (10 mL SQL70 and 500 mg/m^2/ of SQP33 for 2 Days and and 250 mg/m^2/ of SQP33 for 1 Day) | 0 | |
| P2a Grp 2 (10 mL SQL70 and 250 mg/m^2/Day of SQP33 for Five Days) | 1 |
Time frame: 1 year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Dose Escalation Cohort 1 (… | Dose Escalation Cohort 2 (… | Dose Escalation Cohort 3 (… | Dose Escalation Cohort 4 (… | Dose Escalation Cohort 5 (… | Dose Escalation Cohort 6 (… | Dose Escalation Cohort 7 (… | Dose Escalation Cohort 8 (… | Dose Escalation Cohort 9 (… | Dose Escalation Cohort (20… | Dose Escalation Cohort (20… | Cohort A (10 mL SQL70 and … | Phase 2a Expansion Group 1… | P2a Grp 2 (10 mL SQL70 and… | P2a Grp 2 (10 mL SQL70 and… |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Haemorrhagic transformation stroke | Nervous system disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| COVID-19 | Infections and infestations | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Device related infection | Infections and infestations | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Flank pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| General physical health deterioration | General disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Hypotension | Vascular disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Pelvic venous thrombosis | Vascular disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Sepsis | Infections and infestations | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Troponin T increased | Investigations | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Urosepsis | Infections and infestations | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Prohormone brain natriuretic peptide increased | Investigations | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Chills | General disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Pancytopenia | Blood and lymphatic system disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Reaction | System | Dose Escalation Cohort 1 (… | Dose Escalation Cohort 2 (… | Dose Escalation Cohort 3 (… | Dose Escalation Cohort 4 (… | Dose Escalation Cohort 5 (… | Dose Escalation Cohort 6 (… | Dose Escalation Cohort 7 (… | Dose Escalation Cohort 8 (… | Dose Escalation Cohort 9 (… | Dose Escalation Cohort (20… | Dose Escalation Cohort (20… | Cohort A (10 mL SQL70 and … | Phase 2a Expansion Group 1… | P2a Grp 2 (10 mL SQL70 and… | P2a Grp 2 (10 mL SQL70 and… |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Fatigue | General disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Chills | General disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Decreased Appetite | Metabolism and nutrition disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Covid-19 | Infections and infestations | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Stomatitis | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Injection Site Pain | General disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Urinary Tract Infection | Infections and infestations | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Oral Candidiasis | Infections and infestations | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Dry Eye | Eye disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Neuropathy Peripheral | Nervous system disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Procedural Pain | Injury, poisoning and procedural complications | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Abdominal Pain Upper | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Abdominal Discomfort | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Abdominal Distension | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Abdominal Pain Lower | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Colonic Fistula | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Dysphagia | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Lip Pain | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Umbilical Hernia | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Oedema Peripheral | General disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Non-Cardiac Chest Pain | General disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Pain | General disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Catheter Site Erythema | General disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Face Oedema | General disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| General Physical Health Deterioration | General disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
Most-reported serious reactions: Neutropenia, Dehydration, Thrombocytopenia, Haemorrhagic transformation stroke, Anaemia, COVID-19, Device related infection, Dyspnoea.
Data from ClinicalTrials.gov NCT04106492 adverse events section.
The purpose of this study is to evaluate the safety, tolerability, and preliminary activity of SQ3370 in patients with advanced solid tumors.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Currently open trials in the same condition.
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/NCT04106492.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing