The Safety and Pharmacokinetics Preliminary Efficacy of IMP7068 in Patients With Advanced Solid Tumors

Key Inclusion Criteria:

1. The patient must voluntarily participate in this clinical study. Be willing and ableto provide written informed consent form (ICF) prior to any study activity.
2. Age ≥18 years on the day of signing the ICF, males or females. Only for Korea, Age ≥19years on the day of signing the ICF.
3. The enrolled patients must have histologically or cytologically confirmed advancedsolid tumor that is refractory/intolerant to standard treatment or for which nostandard treatment exists. The patients with known microsatellite-instability high (MSI-H) or deficient in mismatch repair (dMMR) disease are required to have receivedprior PD 1/PD-L1 therapy; those with known NTRK fusion are required to have receivedan approved TRK-inhibitor. The patients who are suitable for resection or otherlocalized therapy that is potentially curative are not eligible.

Key Exclusion Criteria:

1. Patients with active or untreated known CNS metastases and/or carcinomatous meningitisshould be excluded.
2. Patients with serious acute or chronic infections.
3. Patients who have received prescription or non-prescription drugs or other productsknown to be sensitive to CYP3A4 substrates or CYP3A4 substrates with a narrowtherapeutic index, or to be moderate to strong inhibitors/inducers of CYP3A4 whichcannot be discontinued 7 days prior to Day 1 of dosing and withheld throughout thestudy until 2 weeks after the last dose of IMP7068.
4. Patients who are participating in or have participated in a study of aninvestigational agent and received study therapy or used an investigational devicewithin 28 days of the first dose of treatment.
5. Patients have not recovered (i.e., to Grade ≤1 or to baseline, as evaluated byNCI-CTCAE Version 5.0) from prior anti-cancer therapy-induced AEs, except foralopecia, anorexia or CTCAE grade 2 peripheral neuropathy.
6. Patients who have undergone a major surgery or have undergone a radical radiotherapywithin 28 days prior to the study treatment, or have undergone a palliativeradiotherapy within 14 days prior to the study treatment, or have used a radioactivedrug (Strontium, Samarium, etc.) within 56 days prior to the study treatment.
7. Patients who are unable to swallow oral medications. Patients have gastrointestinalillnesses that may clinically significantly affect the absorption of oral medicationIMP7068 at discretion of investigators.