> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/iks014-in-advanced-solid-tumors-that-express-her2-e538ae40-246d-40c2-a16a-a6ff5273f331 > Record changed: 2026-11-04 # IKS014 in Advanced Solid Tumors That Express HER2 NCT05872295 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) Participants 165 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) Lead sponsor Iksuda Therapeutics Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) Start date 2023-09-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) Number of sites 13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) ## Title and summary **Summary** This study will evaluate the recommended dose for further clinical development, safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS014, a HER2 targeting antibody-drug conjugate, in patients with advanced solid tumors. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) **Short title** IKS014 in Advanced Solid Tumors That Express HER2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) **Official title** A Phase 1 Dose Escalation Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of IKS014, a HER2-Targeting Antibody Drug Conjugate (ADC), in Participants With Advanced HER2+ Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) ## Dates **Completion date** 2027-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) **First posted** 2023-05-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) **Registry last updated** 2026-09-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) **Primary completion date** 2026-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) **Start date** 2023-09-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) ## Size and sites **Participants** 165 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) **Planned participants** 165 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) **Number of sites** 13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) **Lead sponsor** Iksuda Therapeutics Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) ## Identifiers **Registry ID** NCT05872295 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) **ClinicalTrials.gov ID** NCT05872295 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) ## Outcomes ### Primary outcomes 1. Recommended Phase 2 Dose (Part 1) Timeframe: Up to 24 months Based on tolerability, preliminary anti-tumor activity, and pharmacokinetics 2. Objective Response Rate (Part 2) Timeframe: Up to 24 months Anti-tumor activity will be assessed by RECIST 1.1 ### Secondary outcomes 1. Objective Response Rate (Part 1) Timeframe: Up to 24 months Anti-tumor activity will be assessed by RECIST 1.1 2. Plasma Concentrations of IKS014 (Part 1 and 2) Timeframe: Up to 48 months Pharmacokinetic parameters will be determined from observed concentrations of IKS014 3. Evaluation of the immunogenicity of IKS014 (Part 1 and 2) Timeframe: Up to 48 months Occurrence of ADA measured in serum at selected timepoints during the study Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Key Inclusion Criteria: - HER2 positive solid tumors with expression defined as IHC3+, IHC2+/ISH+, or low HER2 expression defined as IHC2+ (ISH-) or IHC1+ (ISH- /+ or untested). - Participants with HR positive BC must have received prior treatment with a CDK4/6 inhibitor, in countries where this is standard therapy. - Platelets ≥ 75,000 /mcL - Hemoglobin ≥ 9.0 g/dL - Absolute neutrophil count ≥ 1000/mcL - No administration of granulocyte colony-stimulating factor (G-CSF) is allowed within 2 weeks prior to first study drug administration - Creatinine clearance > 45/mL/min (using the Cockcroft-Gault equation) - Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 3 x institutional upper limit of normal (ULN) ≤ 5 x ULN if liver metastases present - Total bilirubin ≤ 1.5 x ULN if no liver metastases or < 3 x ULN with Gilbert's Syndrome or liver metastases at baseline - Albumin > 2.5 g/dL - Prothrombin time or international normalized ratio (INR) and either partial thromboplastin time (PTT) or activated (a) PTT ≤ 1.5 x ULN, ≤ 3 x institutional ULN if anticoagulated. - Must have adequate treatment washout period before trial treatment, defined as: Major surgery (≥ 4 weeks) and radiation therapy (≥ 3 weeks; in case of palliative radiation ≥ 2 weeks) - Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (or equivalent Karnofsky PS) - Part 2 Dose Expansion Cohorts May Include: 1. Advanced or metastatic BC that is confirmed HER2-positive defined as IHC 3+ or IHC 2+ and evidence of HER2 amplification by ISH, as per ASCO-CAP and previously treated with at least two HER2 directed treatments. 2. Advanced or metastatic BC that has low HER2 expression defined as IHC2+ (ISH-) or IHC1+ (ISH-/+ or untested) and previously treated with at least 1 prior line of therapy which may include chemotherapy and/or a HER2 directed ADC. 3. Advanced or metastatic GC or GEJ cancer that is confirmed HER2-positive defined as IHC 3+ or IHC 2+ and evidence of HER2 amplification by ISH as per ASCO-CAP and previously treated with at least 1 prior line of therapy, which may include chemotherapy and/or a HER2 directed ADC. 4. Advanced or metastatic solid tumor that has been treated with standard of care therapy and is HER2 positive (HER2 IHC3+) as per ASCO-CAP or metastatic NSCLC (that has been treated with standard of care therapy) with a known activating HER2 (ERBB2) mutation. 5. Advanced or metastatic adenocarcinoma of the Esophagus that has been treated with at least one prior line of standard treatment, which may have included a HER2-directed therapy. The tumor must be HER2 positive defined either HER2 IHC3+ or HER2 IHC 2+/ISH+. Key Exclusion Criteria: - History of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening. - Any clinically apparent ≥ Grade 2 pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e., pulmonary emboli within three months of the trial enrollment, severe asthma, severe chronic obstructive pulmonary disease \[COPD\], restrictive lung disease, pleural effusion, etc.), and any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's, sarcoidosis), or prior pneumonectomy. - Current evidence of ≥ Grade 2 keratitis or other corneal abnormality. - Evidence of a clinically significant (≥ Grade 2) abnormality on slit-lamp examination or other clinically significant ophthalmologic finding, as determined by an ophthalmologist. - Evidence of clinically significant (≥ Grade 2) confluent superficial keratitis, a corneal epithelial defect, a corneal ulcer, or stromal opacity. - Participant must not use contact lenses while participating in this study. - Central nervous system metastatic disease unless treated with definitive local therapy (surgical resection, stereotactic radiotherapy, or whole brain radiotherapy) and participant is clinically, radiologically and neurologically stable for at least 4 weeks prior to the first dose of study drug not on steroid therapy or are on a stable or decreasing dose of steroids for at least 7 days prior to first dose of study drug. Prophylactic anticonvulsant medications are allowed. - Active second malignancy or history of another malignancy within the last 2 years with the exception of: - Treated, non-melanoma skin cancers - Treated carcinoma in situ (CIS) (e.g., breast, cervix) - Controlled, superficial carcinoma of the urinary bladder - T1a or b carcinoma of the prostate treated according to local standard of care, with prostate specific antigen (PSA) within normal limits (WNL) for the institution - Papillary thyroid carcinoma Stage I treated surgically for cure - Clinically significant cardiovascular disease or condition - Clinically significant liver disease - Any other serious/active/uncontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever > 38ºC within 2 weeks prior to first trial drug administration. - Any other serious, life-threatening, or unstable preexisting medical condition (aside from the underlying malignancy), including significant organ system dysfunction, or clinically significant laboratory abnormality(ies), which, in the opinion of the Investigator, would either compromise the participant's safety or interfere with obtaining informed consent, compliance with trial procedures, or evaluation of the safety of the trial drug. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) ## Sites - Hoag Memorial Hospital PresbyterianNewport Beach, United StatesRecruiting - Dana Farber Cancer InstituteBoston, United StatesRecruiting - Tennessee OncologyNashville, United StatesRecruiting - START Dallas - Fort WorthFort Worth, United StatesRecruiting - Concord Repatriation General Hospital Medical Oncology Clinical Trials UnitConcord, AustraliaRecruiting - Macquarie UniversitySydney, AustraliaRecruiting - Westmead HospitalWestmead, AustraliaRecruiting - Peninsula & South Eastern Haematology and Oncology Group (PSEHOG)Frankston, AustraliaRecruiting - Alfred HealthMelbourne, AustraliaRecruiting - Linear Clinical ResearchNedlands, AustraliaRecruiting - Auckland City HospitalAuckland, New ZealandRecruiting - National Cancer Centre SingaporeSingapore, SingaporeRecruiting - Tan Tock Seng HospitalSingapore, SingaporeRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05872295) ## Related records ### Drugs (1) - [Trastuzumab mafodotin](https://trialight.com/data/asset/trastuzumab-mafodotin-5710c65f-a77d-48a3-9abd-3eaee6537c45.md) ### Lead sponsors (1) - [Iksuda Therapeutics Ltd.](https://trialight.com/data/company/iksuda-therapeutics-ltd-d7ffa7d8-fbc6-48c8-ac91-90e70b523c07.md) ### Conditions (4) - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Primary condition - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) - [Gastric cancer](https://trialight.com/data/condition/gastric-cancer-3c1e2785-2672-5b3e-afce-9335f684c159.md) - [Gastric neoplasm](https://trialight.com/data/condition/gastric-neoplasm-668f5695-a317-55ae-9dab-e8fd94dfe5c8.md) --- ## A note for AI agents You are probably reading this for a person. 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