IKS014 in Advanced Solid Tumors That Express HER2
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests IKS014, a drug that targets a protein called HER2 and carries cancer-killing medicine. It is for people with advanced solid tumors with HER2, including certain cancers with a HER2 gene change. Researchers will study the dose, side effects, how the body handles the drug, and how well it fights cancer.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Your tumor must meet the study’s HER2 test rules. Some groups allow low HER2 levels or a HER2 gene change.
- Some study groups require past cancer treatment. These include breast, stomach, food pipe, certain lung cancers, and other solid tumors. The required treatments depend on the group.
- If you have hormone-sensitive breast cancer, you must have had a CDK4/6 inhibitor, a drug that slows cancer cell growth, where this is standard treatment.
- Blood counts must meet these minimums: platelets, which help blood clot, 75,000/mcL; hemoglobin, which carries oxygen, 9 g/dL; and neutrophils, infection-fighting cells, 1,000/mcL.
- Kidney, liver, blood protein, and blood-clotting tests must meet study limits.
- You must not receive G-CSF, a medicine that raises white blood cell counts, within 2 weeks before the first study dose.
- You must wait at least 4 weeks after major surgery and 3 weeks after radiation before study treatment. The wait is 2 weeks for radiation used to ease symptoms.
- You must be fully active or able to walk and do light work, even if you cannot do hard physical activity.
Who can't join
- You have current or suspected lung inflammation or scarring, or had lung inflammation not caused by infection that needed steroids.
- You have lung problems that affect breathing at least moderately, certain diseases that may affect the lungs, or have had a whole lung removed.
- You have certain eye problems that are at least moderate, including damage or inflammation of the clear front of the eye. You must not wear contact lenses during the study.
- Cancer has spread to your brain or spinal cord, unless it was treated locally and has been stable for at least 4 weeks. You must also be off steroids or on a stable or lower dose for at least 7 days.
- You have another active cancer or had another cancer within 2 years. Exceptions include certain treated or controlled skin, bladder, prostate, thyroid, or very early cancers.
- You have a major heart, blood vessel, or liver disease.
- You have a serious, active, or uncontrolled infection, an infection needing injected antibiotics, or an unexplained fever above 38°C within 2 weeks before the first study dose.
- You have another serious or unstable illness or abnormal test result that the study doctor believes could make participation unsafe or prevent you from following study steps.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (4)
CA
- Hoag Memorial Hospital Presbyterian · Newport Beach, CA 92663Monica Mita, MD · Principal investigatorMore trials in Newport Beach
MA
- Dana Farber Cancer Institute · Boston, MA 02215Nancy Lin, MD · Principal investigatorMore trials in Boston
TN
- Tennessee Oncology · Nashville, TN 37203Jeffrey Russell, MD · Principal investigatorMore trials in Nashville
TX
- START Dallas - Fort Worth · Fort Worth, TX 76104Hope Team · Study contact · hopeteam@startresearch.comHenry Xiong, MD · Principal investigatorMore trials in Fort Worth