🧪 Newly & Currently Recruiting Trials

Inclusion Criteria: * Histologically or cytologically documented refractory solid tumors that are recurrent or metastatic including: HNSCC (excluding EBV-positive nasopharyngeal carcinoma), NSCLC, esophageal/gastric cancer, colorectal cancer, endometrial carcinoma, urothelial carcinoma, and breast cancer (HR-positive \[HER2-positive or HER2-negative\] and TNBC subtype) * Age ≥ 18 years * Life expectancy of at least 3 months * Willingness and ability to comply with the study protocol and long * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1-term follow-up (LTFU) assessments * Has received standard systemic therapies with known clinical benefit, or is considered inappropriate for such therapies, in the opinion of the investigator. In the dose escalation Phases (Parts 1A and 1C), there is no limit on the number of prior therapies * Expansion Phase (Part 1B) only: Up to two prior therapies are allowed. For participants with AGA-driven adenocarcinoma NSCLC up to four prior therapies are allowed * Measurable disease per RECIST v1.1. * Adequate hematologic and organ function Exclusion Criteria: * Prior anticancer treatment with an ADC with a TOP1 inhibitor payload. (Prior therapy with an ITGB6-targeted ADC is otherwise allowed.) * Prior anticancer therapy (prior to first dose of study treatment): chemotherapy within ≤ 2 weeks, ICI ≤ 3 weeks, ADCs ≤ 3 weeks, palliative radiation therapy ≤ 2 weeks, and major surgery ≤ 4 weeks of C1D1. If not specified, ≥ 5 half-lives or 2 weeks, whichever is longer, since administration of prior therapy must have elapsed * Residual Common Terminology Criteria for Adverse Events (CTCAE) v5 ≥ Grade 2 toxicity from prior anticancer therapy, with the exception of Grade 2 alopecia or Grade 2 peripheral neuropathy, which is controlled, and endocrinopathies secondary to prior ICI controlled by hormonal treatment. For Part 1C only: discontinued prior immunotherapy due to treatment-related toxicity * Untreated or active brain metastases and/or leptomeningeal disease * Participants with active ILD or active, non-infectious pneumonitis or a history of active pneumonitis ≤ 6 months from the first dose of study treatment * Significant, concurrent renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric disease that could impact participation in this clinical trial * Previous solid organ or bone marrow transplantation * Concurrent participation in another therapeutic treatment trial

Main Inclusion Criteria: 1. Has histologically or cytologically documented locally advanced or metastatic high-grade serous epithelial ovarian cancer, including ovarian, fallopian tube, or primary peritoneal carcinoma, that is not amenable to curative surgery or radiotherapy, and has demonstrated radiographic disease progression on the most recent line of systemic therapy. 2. Prior exposure to a platinum-containing regimen is mandatory. Platinum-resistant disease is defined as disease progression during or within 6 months following completion of the most recent platinum-containing regimen. Patients with platinum-sensitive disease may be eligible during Phase 1 if they have received at least 2 prior lines of platinum-containing systemic therapy. 3. Prior Lines of therapy: Subjects must have received at least one (≥1) and no more than four (≤4) prior lines of systemic therapy in the advanced or metastatic setting and have progressed on, been intolerant to, or be ineligible for standard therapies available in their local region. Prior treatment with mirvetuximab soravtansine and/or bevacizumab is permitted but not required, reflecting regional differences in standard of care, regulatory approval status, availability, or access. Hormonal therapy and maintenance therapy, including PARP inhibitors or bevacizumab maintenance, are not counted as prior lines of systemic therapy unless administered for treatment of progressive disease. 4. Have at least one measurable lesion by RECIST v1.1 (Eisenhauer et al., 2009) for solid tumors; 5. ≥18 years old; 6. Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) of 0 to 1; 7. Life expectancy of ≥12 weeks; 8. Patients with adequate organ function and the laboratory test criteria specifically defined as follows within 7 days prior to the first dosing; Main Exclusion Criteria: 1. Has know hypersensitivity to any component of TJ102 or has a history of severe hypersensitivity reactions to other monoclonal antibodies. 2. Has received more than two (2) prior antibody-drug conjugate (ADC) therapies in the advanced or metastatic disease setting, including ADCs containing topoisomerase I inhibitor payloads (e.g., SN-38, DXd, exatecan derivatives) or antimicrotubule payloads (e.g., MMAE, DM1/DM4, auristatins, maytansinoids). 3. Prior therapy with any antibody-drug conjugate (ADC) whose cytotoxic payload is eribulin or a structural derivative thereof is prohibited in the advanced/metastatic disease setting. 4. Has received mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration; oral fluorouracil-like drugs such as S-1, capecitabine, or palliative radiotherapy within 2 weeks prior to the first administration; Has received other chemotherapy, biological therapy, major surgery, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase) and other anti-tumor therapy within 5 half-lives or 28 days, whichever is shorter, prior to the first administration of TJ102; Has received anti-tumor herbal medicine within 14 days prior to first dose of TJ102; 5. Has received a strong or moderate CYP3A4 inhibitor within 3 half-lives prior to first dose of TJ102; 6. Received an investigational drug within 28 days or 2 half-lives (whichever is shorter) prior to first dose of TJ102; Current participation in other interventional clinical studies (participation in survival follow-up is allowed); 7. Toxic effects of prior anti-tumor therapy have not recovered to NCI-CTCAE V6.0 Grade ≤1 (excluding alopecia and skin pigmentation). Subject with irreversible toxicities caused by prior anti-tumor therapy (eg, hearing loss) that will not increase the safety risk may be eligible per the discretion of the Investigator; 8. Has a history of (non-infectious) interstitial lung disease (ILD) that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis can't be ruled out by imaging at screening; 9. Presence of severe dry eye syndrome, severe keratitis, severe conjunctivitis, or other severe conditions that may increase the risk of corneal epithelial damage at the discretion of investigator; 10. Presence of Grade ≥2 or history of Grade ≥3 peripheral neuropathy. 11. Uncontrolled or significant cardiovascular disease 12. For patients with documented positive virology status, as confirmed by Screening hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) tests, only the following patients may be eligible as evaluated by the sponsor and investigator: Patients with active hepatitis B: HBV DNA ≤500 IU/mL during Screening. Patients who are hepatitis C virus antibody positive (HCV Ab+), should have controlled infection (HCV RNA≤ULN by polymerase chain reaction \[PCR\] either spontaneously or in response to a successful prior course of anti-HCV therapy at Screening). Patients with controlled infections must undergo periodic monitoring of HCV RNA as per treating physician. 13. Severe infection, including but not limited to hospitalization due to infection, bacteraemia, or severe pneumonia complications, occurs within 4 weeks prior to initiation of study treatment; Or patients who received therapeutic oral or intravenous antibiotics and who received prophylactic antibiotics (e.g., for the prevention of urinary tract infection or chronic obstructive pulmonary disease) within two weeks prior to starting study treatment. 14. Active central nervous system (CNS) metastases or meningeal metastases. Subjects may be enrolled in the study if their CNS metastases have received adequate local therapy and have been clinical stable for at least 4 weeks (i.e., imaging shows no progression of the brain lesion and neurologically relevant symptoms are stable), and require a dose of prednisone of ≤20 mg/day (or equivalent dose). Subjects with untreated CNS metastases are excluded. 15. Other malignancies within 3 years prior to initiation of study treatment (Note: does not include tumors with a negligible risk for metastasis or death, eg, non-melanoma basal cell carcinoma or squamous cell carcinoma of the skin, breast/cervical carcinoma in situ, superficial bladder carcinoma that have received radical treatment and without evidence of disease recurrence); 16. Female patients who are lactating or breastfeeding; 17. The investigator believes that the subject may have other factors that may affect the results of the study and interfere with the subject's participation in the entire study process, including previous or existing physical conditions, abnormal treatment or laboratory tests, and the subject's unwillingness to comply with all procedures, restrictions, and requirements of the study.

Abridged Inclusion Criteria: 1. Capable of giving signed informed consent: Regulatory, Ethical, and Trial Oversight Considerations which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 2. Subjects age \> 18 years at the time of trial entry. 3. Pathologically proven platinum-resistant epithelial ovarian, fallopian, or primary peritoneal cancer, with high-grade serous ovarian carcinoma (HGSOC) or a predominantly serous/endometroid component. Platinum-resistant disease, defined as disease progression within 6 months of last dose of platinum-based chemotherapy. 4. Maximum of 2 prior regimens for platinum-resistant disease. Subjects who are positive for high FR alpha (defined per the FDA approved companion diagnostic test (ELAHERE prescribing information) must have received MIRV. Candidates for MIRV with contraindications or documented intolerance are eligible pending documentation of discussion with the Medical Monitor. 5. CT/MRI evidence of measurable disease per RECIST Version 1.1 defined as at least one lesion not previously irradiated that can be measured at baseline as 10 mm in the longest diameter (except lymph nodes which must have a short axis of 15 mm). Tumor lesions in previously irradiated area or in area subject to other loco-regional therapy are usually not considered measurable unless progression has been demonstrated in the lesion. Lesions selected as targets for response assessment should not be biopsied. 6. ECOG performance status of 0-1 7. Subjects with known central nervous system metastasis must have undergone brain targeted treatment and must be asymptomatic or radiographically and clinically stable (including not requiring steroids or anti-seizure medications) for at least 4 weeks prior to enrollment. 8. Subjects must have adequate organ function as indicated by the following laboratory values: 1. Absolute neutrophil count (ANC) ≥ 1,500 /mL 2. Platelets ≥ 100,000 / mL 3. Hemoglobin ≥ 9 g/dL 4. Serum creatinine ≤ 1.5 X upper limit of normal (ULN) 5. Serum total bilirubin ≤ 1.5 × ULN 6. Aspartate aminotransferase (AST), (Serum glutamic oxaloacetic transaminase \[SGOT\]), alanine aminotransferase (ALT), and (Serum glutamic pyruvic transaminase \[SGPT\]) ≤ 2.5 × ULN OR ≤ 5 × ULN for subjects with liver metastasis 7. International Normalized Ratio (INR) and/or Prothrombin Time (PT) ≤ 1.5 × ULN 8. Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN 9. Serum Albumin ≥ 3 g/dL measured at two time points: no less than 2 weeks before the 1st dose of misetionamide and within one week prior to the 1st dose. Subjects showing a decrease of \> 20% at the 2nd measurement are excluded. 9. Limited concomitant radiotherapy for pain control is allowed in the 5 weeks prior to initial dose. 10. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test. 11. Subjects must use adequate contraception for the duration of the trial and for at least 3 months after the last dose and refrain from tissue donation during this period. . 12. All acute toxic effects of any prior anti-tumor therapy resolved to Grade \< 1or baseline before start of dosing (exceptions are alopecia and Grade 2 peripheral neuropathy). Abridged Exclusion Criteria: 1. Diagnosis of any active malignancy other than platinum-resistant ovarian cancer within the past 2 years (not including non-melanoma skin carcinoma, ductal carcinoma in situ of the breast, or carcinoma in situ of uterine cervix treated with curative intent). 2. Subjects has a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonia or multiple allergies, clinically significant cardiovascular disease such as unstable angina, myocardial infarction, or acute coronary syndrome within \< 6 months prior to the start of study treatment, symptomatic or uncontrolled arrhythmia, congestive heart failure, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or ascites requiring paracentesis in the 4 weeks prior to Screening. 3. Primary refractory disease (defined as failure to achieve at least a partial response (PR) to their initial platinum-based chemotherapy). 4. Radiotherapy (RT) to target lesions, chemotherapy, or other systemic anti-cancer therapy, including prior anti-angiogenic treatment (e.g. bevacizumab) within 4 weeks prior to starting treatment. 5. Ascites including history of therapeutic paracentesis within the 2 weeks prior to signing informed consent. 6. Any other medical, psychiatric, or social condition deemed by the Investigator to be likely to interfere with a subject's rights, safety, welfare, or ability to sign informed consent, cooperate and participate in the trial, or which would interfere with the interpretation of the results. 7. Subject has undergone major surgery, other than diagnostic surgery within 4 weeks prior to Day 1 of treatment in this study. 8. Prior history or current signs of hyphema or glaucoma. 9. History of sickle cell disease or hereditary non-spherocytic hemolytic anemia. 10. Baseline QTc interval \>480 msec for female subjects or \>450 msec for male subjects. 11. Subject is unwilling or unable to comply with study procedures or planning to take a vacation for \>7 consecutive days during the course of the study. 12. First degree relative of the investigator, study staff or the sponsor. 13. Any chemotherapy administered within 3 weeks or 5 half-lives (whichever is shorter) before first dose of misetionamide; other anti-cancer therapy (including surgery, radiotherapy, immunotherapy, hormone therapy, or targeted therapy) administered within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of misetionamide; or within 6 weeks in the case of certain therapies (mitomycin C and nitrosoureas). 14. Investigational therapy administered within 4 weeks or 5-half lives (whichever is shorter) before the first dose of misetionamide.